Amgen

Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Career Category Finance Job Description Job Summary Amgen is searching for a Senior Associate to support the Biosimilars Business Unit (BBU). This role will support the Biosimilars team through budget management, forecasting support, external partnership management and valuation analysis This role will interface regularly with the consolidation group for GCO and will be based in the main corporate campus in Thousand Oaks, CA. The Sr. Associate will provide financial support and be a business partner with the BBU and Commercial Operations leadership. Job Responsibilities Planning, tracking and reporting of the financial impacts of ongoing operations within the financial reporting system Supporting annual budget, quarterly forecast and long-range forecast planning processes Maintaining financial models detailing expected spend, projected P&Ls and the value of the biosimilar portfolio Supporting quarterly close processes for the BBU and related functions Preparing financial reports and analysis to support alliance management activities with current partners Partnering with functional finance teams, accounting and strategic sourcing on committed and projected spend Performing ad hoc analysis for BBU decision support, strategic assessments, scenario analysis and business development opportunities Serving as the secondary resource and point of contact for finance-related matters for the BBU Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Finance/Accounting experience OR Associate's degree and 6 years of Finance/Accounting experience OR High school diploma / GED and 8 years of Finance/Accounting experience Preferred Qualifications BA/BS in Accounting, Finance, Business or related discipline Pharmaceutical/Biotech experience Prior experience with financial and valuation models and strong proficiency with Excel and PowerPoint Experience in Financial Planning & Analysis or Accounting roles Strong analytical skills with the ability to analyze data and present results to senior management in a professional, clear and concise manner Experience with SAP, Hyperion and/or other large Enterprise Resource Planning (ERP) and consolidation tools Advanced MS Excel and PowerPoint proficiency Ability to multi-task, prioritize and lead multiple projects Detail oriented and able to handle fast paced environment while delivering timely results Strong written, verbal communication and presentation skills (English and Spanish) Exceptional interpersonal skills; and ability to influence at all levels, functions and geographies Comfortable supporting a wide range of client levels Ability to demonstrate judgment and make appropriate recommendations Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .
Amgen Rhode Island, USA
Oct 20, 2019
Full time
The Senior Instrument Technician will report to a Manager of Maintenance. The Senior Instrument Technician is responsible for performing calibration, repair, installation, and troubleshooting of instruments, process control systems, and equipment used in ARI site. Shift: Rotating Days (7pm - 7am) Responsibilities: Perform instrument calibrations for process, utility and analytical equipment and systems Troubleshoot and repair site instrumentation and control system issues Perform advanced maintenance and repair activities on equipment and systems used in Manufacturing, The Process Develop Laboratory, The Quality Analytical Laboratory or other areas of the ARI site. Ensure activities are accomplished in a safe manner. Ensure work is completed in accordance with procedures. Ensure work activities are completed correctly. Maximize right the first time execution. Work in a highly productive and efficient manner to maximize the quantity of activities completed. Ensure work is appropriately communicated to system operators and key stakeholders. Ensure work order documentation is completed accurately and completely. Identify waste, work flow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation. Identify opportunities to learn new skills and actively participate in development that will improve overall team performance. Provide support when required - this may be outside of normal working hours including nights, weekends and holidays. Basic Qualifications: Associate's degree and 4 years of Maintenance or Instrumentation experience OR High school diploma / GED and 6 years of Maintenance or Instrumentation experience Preferred Qualifications : 8 + years of combined education, training, and experience with instrumentation and associated calibration procedures Ability to work with minimum direction Knowledge of Maximo CMMS System Advanced understanding of process control loops, loop checks, and loop tuning of process control systems Experience with Rosemount instrumentation, Foundation Fieldbus communications, and Delta V process control system Formal instrumentation education or training (Associates Degree, Armed Services, or other substantial technical training program(s)) Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Job Summary The Compliance Systems Manager, Business Process Management is a global role within Amgen's R&D Quality organization. Reporting to the Senior Manager, Business Process Management, and based at Amgen's corporate headquarters in Thousand Oaks, California, the primary objective of the Business Process Management group is to provide leadership and technical expertise for Business Process Management methodology to ensure key R&D processes are effective, efficient and embedded into the Quality Management System (QMS) as well as integrated into Amgen's overall continuous improvement strategy. This role will provide Business Process Management expertise and Quality Management System leadership to the R&D organization through: Defining Business Process Management System solutions based on user/client needs and exploring opportunity to integrate with other QMS systems Developing/maintaining reports for R&D's Business Process Management System Designing and developing process modelling tools, methods and systems Ensuring software meets all requirements for quality, security, modifiability and other areas. Implementing and ensuring adherence to Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN) Managing process definition modeling projects and leading identification of end-to-end processes Defining key compliance and quality metrics for processes Strengthening and advancing Amgen's R&D QMS Contributing to targeted process reviews and process improvement efforts Basic Qualifications Doctorate degree OR Master's degree and 3 years of Quality/Compliance/Process Management experience OR Bachelor's degree and 5 years of Quality/Compliance/Process Management experience OR Associate's degree and 10 years of Quality/Compliance/Process Management experience OR High school diploma / GED and 12 years of Quality/Compliance/Process Management experience Preferred Qualifications Bachelor's Degree with four years of quality, compliance and process/project management experience in the biopharmaceutical industry Experience using/maintaining Business Process Management Systems Experience as business analyst or business/systems architect Experience with architectural design and implementation of system Experience with Application Programming Interface (API) Advanced skills in Visio and Excel, including macros Advanced skills in Business Intelligence reporting (Tableau, Power BI, Spotfire, etc.) Advanced SQL knowledge In-depth knowledge of relational databases Working knowledge of global regulations impacting R&D activities Experience in QMS oversight and implementation Expertise writing technical documentation Knowledge of process management and operational excellence systems, methods and tools Yellow or Green Belt certification Proven ability to lead, influence and facilitate cross functional teams Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Job Summary In this role, the US Regional Planner will serve as a Junior Regional Operations Lead (ROL) within the US regional operations team. The regional planner will manage a portfolio of stable, efficient products and will participate in the overall Integrated Business Planning (IBP) process for their assigned products. These activities include, but are not limited to demand consolidation, metric tracking, strategic life cycle management activities and operational excellence projects. This role includes cross-functional collaboration to establish strong relationships to ensure supply for the US market along with the opportunity to grow into increasing responsibility for more complex product planning and regional operations lead roles. Responsibilities Include: Demand Consolidation Review aggregate unit forecasts in preparation for demand consensus meetings Participate in the monthly demand consensus meetings between commercial finance and Regional Operations Leads to drive a demand consensus forecast used for generating finished good supply plans Prepare demand hand off summaries and forecast metric reporting Supply Planning Develop regional network supply strategy with Global Supply Chain and Sites Own undisrupted patient supply, supply risk assessment and mitigation plans for assigned products Support Demand and Supply Alignment activities for assigned product/market Represent the supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the planning horizon Participate in operational planning and execution of product life-cycle events; coordinates cross-functional activities between Supply Chain, Operations, Regulatory, Marketing, TPCM (Trade, Pricing and Contract Management), Access and Reimbursement and IS Project Management Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management/governance Own and manage change control records driven by the US Region Support non-conformance investigations, follow up and closeout for the US Supply Chain Organization Actively participate in GMP audits and quality management reviews Operational Excellence Monitor and report regional specific supply chain metrics Manage and report on inventory status Participate in department process improvement activities Participate in Operational Excellence opportunities and drive regional improvements and cost savings by leveraging Network Knowledge sharing forums Some international and domestic travel possible but less than 15%. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Bachelor's degree in Engineering, Business Management or Life Science, or advanced degree Significant experience in regulated manufacturing or supply chain setting Demonstrated experience in a continuous improvement role utilizing tools, methodologies and change management (i.e. Lean, Six Sigma) Demonstrated experience in ability to effectively engage diverse, global stakeholder groups and manage projects with multiple, cross-functional deliverables Proven communication and facilitation skills, demonstrated experience in SAP and RapidResponse and/or ERP environments Demonstrated strong analytical skills, business acumen and risk management Training and/or demonstrated experience in manufacturing systems Competencies Knowledge and Technical Expertise Understand basics of quality systems and manufacturing processes Uses supply chain expertise to identify and resolve conflicts between procedures, requirements, regulations, and policies Able to apply principles of finance and accounting Leverages basic Operational Excellence and project management skills Accountability and Responsibility Effectively manages internal and external stakeholder relationships Re-prioritizes work during unexpected situations or changing customer needs Establishes performance metrics to continually improve performance Communication Adapts communication style and works effectively across geographies and cultures Conducts presentations and briefings to Sr Management Collaborates with partners by considering input and promoting trust among all parties Problem solving and decision making Effectively navigates through ambiguity to resolve issues Streamline processes using Operational Excellence methodology and tools Conducts scenario analyses to evaluate implications of different courses of action Maintains composure and direction in high-level situations Teamwork and Leadership Influences and inspires without authority Collaborates and builds constructive cross-functional relationships Effectively manages and resolves conflicts Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Rico, CO 81332, USA
Oct 20, 2019
Full time
Are you looking for a meaningful new opportunity to test and growth your manufacturing processes' skills? We have an immediate need for an Associate Manufacturing to join AML's Formulation & Filling Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. The Role Under general supervision, performs manufacturing processes for cleaning, sterilization and raw materials dispensing according to Standard Operating Procedures in a Formulation & Filling Facility in a Non Standard Shift operations. SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures Perform and monitor critical processes Execute routine validation protocols Follow GMP's Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports). Initiate Quality incidents Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize & accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May train staff to perform hands-on tasks May act as safety representative May assist with system ownership responsibilities Basic education & experience Bachelor's degree Beyond that you will also need: Educational background in Life Sciences or Engineering Experience in Formulation and Filling organization Mechanical ability/expertise Understand equipment/processes which leads to greater independent judgment Basic statistical mathematical skills Technical writing capability GMP knowledge with ability to interpret & apply Interaction and seek outside resources as needed Understand methods for manufacturing area Specific system/equipment skills Basic project management skills Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Downtown, Los Angeles, CA, USA
Oct 20, 2019
Full time
Job Description This is a field-based position within the Health Outcomes and Pharmacoeconomics (HOPE) Medical Science Liaisons (MSL) group in Scientific Affairs, reporting to a Director. The geographic region for this position is Southern California/HI and national accounts as assigned. Purpose: To develop programs, activities and relationships, both externally and internally to Amgen, in order to advance the value and clinical knowledge of our products to the payer community. Responsibilities: The successful candidate will be responsible for fulfilling all aspects of the regional medical liaison role pertaining to payer and formulary support, opinion leader development, value development study support, and product support. Key activities: This position is with the HOPE MSL group and will be located in the stated geography. Key activities include: 1. Provide Payer and Formulary Support through value and medical presentations that focus on therapeutic as well as economic outcomes and utilization aspects of products, and in clinical policy discussions such as evidence-based medicine, clinical guidelines and prior authorization in areas where Amgen has therapeutic expertise. 2. Identify, develop, and maintain collaborative relationships with current and future Payer, Policy, and Health Economic and Outcomes Research opinion leaders through identifying speaker opportunities and concepts and letters of intent for investigator supported economics, humanistic outcome, and non-registration clinical studies to support Amgen's product messages within scope. 3. Interact with key internal stakeholders to provide feedback on customer trends in interpreting and using value evidence, reimbursement and payer policy. 4. Provide complex value-based technical information inclusive of medical education, health outcomes and Pharmacoeconomics information and models and research protocol opportunities to appropriate audiences. 5. Represent Amgen Scientific Affairs to designated payer accounts. 6. Represent Amgen to designated thought leaders in health economics and outcomes research for Amgen Global Health Economics (GHE) and Amgen Center for Observational Research (CfOR). 7. Foster scientific information exchange as it relates to reimbursement and coverage policy between the medical community and Amgen. 8. Collect and report competitive intelligence within Amgen's competitive intelligence guidelines. 9. Effectively manage internal relationships, budgets, and T and E within guidelines. 10. Conduct all assigned duties within Amgen compliance guidelines. Basic Qualifications Doctorate degree and 2 years of MSLexperience Preferred Qualifications Pharm.D., Ph.D., M.D. or D.O. - Five (5) + years of related experience in total (post doctoral training -- i.e., residencies and/or fellowships -- can be a part of this related experience), including at least one year focused on clinical practice, clinical research, or medical research - 3+ years of clinical experience (beyond post doctoral training), with a majority of the experience in a payer environment or working with payers, is highly preferred Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Cambridge, MA, USA
Oct 20, 2019
Full time
Amgen is seeking a Global Pharmacovigilance (PV) Scientist Lead to join our team and work from Amgen's beautiful campus in Cambridge, Ma. To learn more about this position: The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The Global PV Scientist Lead works with the Therapeutic Safety Heads to set direction and strategy for safety assessment activities for the medical/scientific operations with responsibility for providing process insight globally for all products. This person is accountable for the staff management of the PV Scientists in the therapeutic area and resource planning. Additionally, the incumbent also serves to support the GSO as a safety expert to work on the safety deliverables. The PV Scientist Lead works closely with the Therapeutic Area Heads (TAH) as well as functional heads to implement new and revised processes and pharmacovigilance standards across GPS. This person will also provide scientific and compliance expertise as needed to GPS. Provides oversight and is an expert advisor to junior PV Scientists to ensure the following activities are performed according to Amgen SOPs across all therapeutic teams. Applicable tasks may vary by product(s) assigned. The PV Scientist Lead is responsible for overseeing more junior scientists in the following activities and /or may be responsible for the following tasks them self: Directs the planning, preparation, writing and review of aggregate reports Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products as needed. Supports and provides oversight to staff with regards to safety in clinical trials including: ore view of SAEs/AEs as needed Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Participate and contribute to study team meetings as requested or needed Signal detection, evaluation, and management: Perform data analysis to evaluate safety observations and write up analysis results Author of Safety Assessment Reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Prepare and deliver presentation of the Global Safety Team's recommendations on safety issues to the cross-functional Executive Safety Committee decision-making body Assist GSO in the development of risk management strategy and activities including: Provides contents for risk management plans Develop or update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities Provide safety contents for filings Perform other activities that are delegated by the GSO Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility The PV Scientist Lead provides strategy and leadership to the Safety Therapeutic Team: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Lead the implementation of new processes and methods within and across the Therapeutic Areas Management Responsibilities Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Assist in the recruitment of talented GPS and AMGEN staff Assist the leadership team to build an organization and processes that will support future department, company, and industry changes Responsible for Safety budget and headcount within their area of responsibility Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Development plans for staff created annually and reviewed quarterly Responsible for staff and organizational development including effective talent management, succession planning and performance management and onboarding Responsible for organizational management through ERP tools, expense report reviews, invoice approvals, timecard review and approval, overtime approval, vacation requests, etc. Distribute work as appropriate and assign staff to teams Processes and regulations for pharmacovigilance and risk management Drug development and lifecycle management Safety data capture in clinical development and post-market settings Safety database structure and conventions MedDRA and other dictionaries used in pharmacovigilance Methods of qualitative and quantitative safety data analysis Product and disease state knowledge General medicine, epidemiology, physiology, and pharmacology Risk management and risk minimization Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling Advanced understanding of interfaces across various pharmacovigilance and risk management processes Internal organizational and governance structure Pharmacovigilance skills-Advanced Skills Signal detection, evaluation and management Aggregate data analysis Sound clinical and scientific judgment Application of medical concepts and terminology Advance skills writing Risk Management plans Data interpretation and synthesis• Ability to convey complex, scientific data in an understandable way Ability to analyze and interpret complex safety data Advanced skills in application of statistical and epidemiological methods to pharmacovigilance Biomedical Literature-Advance skills Literature Surveillance: Advance source document review knowledge and skills Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills Other skills-Advance skills in the following Advance organization, prioritization, planning skills Collaboration with cross-functional team settings Meeting management and time management skills Process and project management Critical scientific assessment and problem solving Written and verbal communications skills, including medical/scientific writing Computer skills (e.g., MS Office Suite and safety systems) Strategic thinking Influencing and negotiation in a cross-functional, matrix environment Presentation skills for conveying complex technical contents to non-expert audiences Team leadership and mentoring in a cross-functional, matrix environment KNOWLEDGE Applies advanced PV subject matter expert within defined subject area Applies expert knowledge and broad understanding of multiple disciplines Understands impact of emerging scientific/technical trends and their implications for Amgen PROBLEM SOLVING Analyzes and forecasts scientific/technical trends Develops complex solutions to problems through in-depth analysis, coordination and negotiation with key decision makers Performs complex work-flow analysis on processes impacting multiple areas across the organization Adapts and integrates own experience with Amgen-wide strategy Develops innovative solutions to problems without precedent Proposes and supports implementation of new processes to achieve strategic business objectives Works in partnership with management to develop business plans that support the direction of the business AUTONOMY Guided by business plans and strategy: Executes strategy, goals and changes within area of responsibility Contributes to strategic decisions affecting the discipline Directs management of program execution and services Guides ideas through development into a final product CONTRIBUTION Contributes to business results through quality of results, advice and decisions related to the operations of the discipline Designs and develops global processes, systems and/or applications Contributes to organizational through leadership May accomplish business results through leveraging a team of professionals and/or managers Develops mutually beneficial strategic alliances with internal and external contacts Serves as a role model and mentor Basic Qualifications: Doctorate degree and 4 years of directly related experience OR Master's degree and 8 years of directly related experience OR Bachelor's degree and 10 years of directly related experience AND..... click apply for full job details
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
The External Planning & Delivery (EPD) Supply Chain Manager will play a critical role in establishing the end-to-end supply chain of Amgen's commercial product portfolio. The EPD Supply Chain Manager will drive commercial planning and delivery of commercial products manufactured at Amgen's Contract Manufacturing Organizations (CMO) in North America and Europe. The overall goal for this position, in tight partnership with Global Supply Chain and Amgen Contract Manufacturing, is to deliver supply in the right product quantity to the right location at the right time, while optimizing inventory and cost within the contractual terms, eliminating stock-out and scrap exposure while improving the overall supply risk profile. Responsibilities The EPD Supply Chain Manager is responsible for: Direct support to Amgen's Integrated Business Processes at the site level, including Plan-To Stock and Order-To-Cash and hand-off processes to contract manufacturers; Managing Purchase Order and Invoice management; Developing standard requirements for Technology Transfer and New Product Introduction to CMO Sites; Ensuring that required Operating Standards are implemented and sustained at managed sites; Effectively engaging key partners within supply chain, quality, finance, process development, operations and other functional areas as needed; Developing and/or delivering reports, presentations and/or recommendations to executive audiences; Serving as a Supply Chain resource and/or representative for special projects and initiatives; Working under minimal supervision in line with Amgen Values and Leadership Attributes. The EPD Supply Chain Manager will carry the following activities per established business processes and procedures. These tasks may vary according to the product portfolio: Production planning: Master data creation (design and set up, change control assessments) Forecasting (interface with planning groups to translate demand into an executable production plan) DS and DP planning and allocation (demand bulk from bulk sites, allocation to production per requirements, manage Weight Allocation Forms with Site) MRP management of supply and demand for DS, DP, and or FDP SAP execution of production orders and material transfer orders Purchase order issuance and approval Invoice review and approval Raw Material Management: Master data creation (design and set up, change control assessments) Order policy determination (order quantities, delivery timing, safety stocks) Forecasting to vendors and internal sites Purchase order management with vendors and internal sites Issue management with vendors and internal sites Invoice review and approval Space planning Logistics: Determine schedules with shipping sites, receiving sites, and raw material vendors Support creation of official Shipping Lanes for GMP product shipments Lead shipping readiness meetings as needed with shipping and receiving sites Provide data for and review of import/export documentation for drug product Provide data for and review of import/export documentation for samples Establish supply lanes with raw material vendors and carriers Generate and provide import/export documentation for raw materials Schedule transportation of raw materials with vendors and carriers Issue management with carriers Authority The position has the authority to (i) approve changes to the product supply and delivery plans within the Amgen-CMO master supply agreement and (ii) issue service purchase orders and related invoices. Outputs Performance measures include: Forecast submission within the Amgen-CMO master supply agreement On time in full delivery Absence of product / raw material scrap and stock-out Basic Qualifications: Doctorate Degree OR Master's Degree + 2 years of Engineering, Business Management or Life Science OR Bachelor's Degree + 4 years of Engineering, Business Management or Life Science OR Associates Degree + 10 years of Engineering, Business Management or Life Science OR High School Diploma/GED + 12 years of Engineering, Business Management or Life Science Preferred Qualifications: Bachelor's degree in Engineering, Business Management or Life Science or advanced degree Significant experience in regulated manufacturing or supply chain setting Demonstrated experience in a continuous improvement role utilizing tools, methodologies and change management (i.e. Lean, Six Sigma) Demonstrated experience in forming-leading-facilitating-inspiring teams Demonstrated ability to effectively engage diverse, global stakeholder groups and manage projects with multiple, cross-functional deliverables Proven communication and facilitation skills Demonstrated experience in SAP and RapidResponse ERP environments Demonstrated negotiation skills with external parties and contract development experience Demonstrated strong analytical skills, business acumen and risk management Training and/or demonstrated experience in manufacturing systems Competencies Knowledge and Technical Expertise Understand basics of quality systems and manufacturing processes Uses supply chain expertise to identify and resolve conflicts between procedures, requirements, regulations, and policies Able to apply principles of finance and accounting Leverages basic Operational Excellence and project management skills Accountability and Responsibility Effectively manages internal and external stakeholder relationships Reprioritizes work during unexpected situations or changing client needs Establishes performance metrics to continually improve performance Communication Adapts communication style and works effectively across geographies and cultures Understands nuances of a matrixed work environment Conducts presentations and briefings to Sr Management Collaborates with partners by considering input and promoting trust among all parties Problem solving and decision making Effectively navigates through ambiguity to resolve issues Streamline processes using Operational Excellence methodology and tools Conducts scenario analyses to evaluate implications of different courses of action Maintains composure and direction in high-level situations Teamwork and Leadership Teamwork and Leadership Influences and inspires without authority Collaborates and builds constructive cross-functional relationships Effectively manages and resolves conflicts Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Columbia, SC, USA
Oct 20, 2019
Full time
The Sales Training Manager ("Field Training Manager") reside in the Cardiovascular, MidAtlantic Region and reports into the Senior Manager, Field Sales Training. The role serves as a developmental opportunity that will involve establishing virtual cross-matrix relationships with sales, marketing and training leaders in Thousand Oaks to develop field-based content to ensure alignment of key sales objectives and related strategies in the field. In addition, the successful candidate will be a dotted line report to the Regional Sales Director and will be responsible for working with the Senior Manager, Field Sales Training, the Director of Learning & Performance and the Regional Sales Director to develop Semester content and lead facilitation of training related workshops at Semester meetings and as needed, as a guest trainer. The qualified candidate will work with the Regional Sales Director to understand the annual sales objectives and translate those into a training and coaching plan that will improve behavioral, performance, and sales outcomes of the Senior Sales Representatives (SSRs). The effective partnership between the Field Sales Trainer and his/her Regional Sales Director will yield more consistent training outcomes, tailored market solutions, sustainability of key execution focus areas and ultimately, drive revenue and customer engagement. In addition, the Field Sales Trainer will learn and incorporate new adult learning techniques/principles to develop innovative approaches and training content for field implementation. This position is an individual contributor role with specific regional training responsibilities and duties. As a remote member of the GCO L&P training team, the successful candidate will need to establish key partnerships with internal trainers and internal cross-functional team members and leaders. Basic Qualifications Doctorate degree OR Master's degree and 2 years of training and/or sales and/or marketing experience OR Bachelor's Degree and 4 years of training and/or sales and/or marketing experience OR Associate's Degree and 10 years of training and/or sales and/or marketing experience OR High school diploma / GED and 12 years of training and/or sales and/or marketing experience Preferred Qualifications 3+ years of training, sales and/or marketing experience within the pharmaceutical, biotech, healthcare, or medical device industries. Experience defining training goals and objectives with key internal clients, establishing, communicating and managing teams to timelines and financial targets Experience working with a sales team, regulatory, legal, compliance, vendor management as a client or functional unit lead Demonstrated self-starter, ability to work under limited supervision and coordinate multiple projects in a detail oriented environment Understanding of Access & Reimbursement environment Experience in / knowledge of Clinical Development High Business Acumen Strong written and verbal Communication skills (Best in class coaching and selling skills) Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Amgen is seeking a Global Safety Physician at its main headquarters in Thousand Oaks, CA to join the GPS-TAS (Global Patient Safety - Therapeutic Areas) organization and will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products. The Global Safety Physician will report to either a Global Safety Officer or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products as designated by GSO or TAH (therapeutic area head). The Global Safety Officer may delegate to the Global Safety Physician. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The Global Safety Physician is responsible for the following: Directs the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products Supports and provides oversight with regards to safety in clinical trials to Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies. Support activities related to new drug applications and other regulatory filings Perform Signal detection, evaluation, and management Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and pharmacovigilance scientist Prepare presentations to the Global Safety Team on safety issues Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities Basic Qualifications MD or equivalent degree from an accredited medical school Preferred Qualifications Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Clinical/medical research experience Product safety in the bio/pharmaceutical industry Inflammation and nephrology knowledge Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Amgen is seeking to hire a Senior Associate Information Systems (IS) Engineer for Regulated Document Management (RDM) on an enterprise application based on Veeva Vault QualityDocs. The successful individual will play a key role in Amgen's RDM product team. You will coordinate with business representatives and be responsible for consulting, technically configuring and testing capabilities related to RDM. You will support the steady-state improvement of the application and provide continued technical hands-on expertise to Amgen business partners. You will help shape the multi-year RDM product roadmap in alignment with the platform vendor and the business partners. You will be an active participant in all phases of the RDM Product Development Life Cycle (PDLC) including: business client expectation and requirement scope management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and supporting the development of business cases for proposed solutions. This role entails the implementation, integration, and support of commercial off the shelf (COTS) application platforms focused on RDM for Life Sciences. Role responsibilities: Work with the business to understand business requirements and processes Collaborate with other IS engineers to understand the application design and functionalities Design and configure Veeva Vault QualityDocs platform to meet business needs Design and execute test scripts (including automation design and execution) Draft Installation Qualification (IQ) and Qualification Testing (QT) protocols Document and close system defects Partner with other test engineers to plan and document testing methods / test scripts to ensure full / sufficient testing of business requirements and system design Perform business modeling, facilitate process mapping and business requirements gathering sessions for medium complex and multi-segment business processes, handle client expectations, configure system settings, and test the system configuration to ensure quality. Basic Qualifications: Master's degree Or Bachelor's degree and 2 years of Information Systems experience Or Associate's degree and 6 years of Information Systems experience Or High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications: Solid grasp of RDM processes is required. This position requires extensive hands-on experience with and understanding of PDLC concepts and approaches, ability to run ongoing system improvements releases, and change control process. Ability to navigate, facilitate and work within a complex matrix organization Ability to work with internal business clients to understand their processes, lead scope of work/expectations and suggest/recommend IS solutions Knowledge of, and experience with, implementing and supporting COTS Regulated Document Management applications in the life sciences industry Hands-on configuration experience with Veeva QualityDocs strongly preferred. A strong desire to grow into a hands-on configurator role is required Experience with agile project methodologies and working in Product teams Extensive experience in leading the IS change control process and running business client expectations Extensive experience in leading the validation of a GxP application Experience and/or understanding of private and multi-tenant cloud deployments and enterprise integrations Excellent written, presentation, and verbal communication skills, including demonstrable experience presenting technology recommendations from a business perspective Knowledge of the biotech/pharmaceutical industry and current approaches to GxP computer related systems Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Tampa, FL, USA
Oct 20, 2019
Full time
Amgen is seeking an Associate of Human Resources who will work on our Employee Services group. The Associate of Human Resources will report to the Human Resource Operations Manager and will work out of Amgen's Capability Center in Tampa, FL. At Amgen, our mission is simple: to serve patients. Our new Tampa Capability Center provides essential services that enable us to better pursue this mission. This state-of-the-art center serves as a base for finance, information systems, and human resources professionals to make a meaningful impact at one of the world's leading biotechnology companies. The Associate of Human Resources will have the opportunity to learn about the many aspects of human resources administration as they provide customer service support to staff members and managers as a member of our service delivery team. Additionally, the Incumbent will work with highly confidential information of all staff at all levels within the organization. Key Activities for the Associate include: Answers telephony inquiries from a dedicated phone line, as well as email inquiries, and triage / escalate issues according to defined processes and procedures; inquires include providing navigational support / answers relating to Amgen's HR system (Workday) while utilizing a knowledgebase program for guidance, an incident management tool to manage inquiries and transactions, and providing excellent customer service as measured by Service Level Agreements and call center metrics Performs transactional work in Workday as well as manages and maintain the content in the team's knowledgebase program and suggest improvements for ongoing development Contributes to improving relationships and service levels with staff and Center of Excellence partners by pro-active communications as well as timely and effective responses Generates standard reports and perform audits on transactional work and other processes Contributes to knowledge sharing within the team. Provide feedback on process and technology improvements Supports and backs up other team members in their daily activities while fostering and sustaining a positive work environment that fosters team performance through own work and behavior Manages other assigned activities Basic Qualifications: Bachelor's degree OR Associate's degree and 4 years of Customer Service experience OR High school diploma / GED and 6 years of Customer Service experience Preferred Qualifications: Fluent in English and Spanish and ability to communicate effectively, both in English and Spanish, verbally and in written word 2+ years' experience in Human Resources, Customer Service or Payroll Effective analytical thinking and attention to detail or related internship experience demonstrating same Strong working knowledge of Microsoft Word, Excel, and Power Point Ability to multi-task in a fast paced environment to meet deadlines Strong team player who is able to collaborate with colleagues on complex tasks Experience supporting a large organization / customer base The hours for this position aligns with supporting the West Coast 11-8 M-F Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Simulation and Modeling Statistician is a biostatistician with work experience in clinical trial design, execution, analysis and reporting; and excellent technical expertise in modeling and simulation. The Senior Statistician works closely with Director, Statistical Innovation (DSI), Strategic Development Director (SDD), the Modeling and Simulation team, EGTs and study teams throughout the evidence generation planning and study design process. The Senior Statistician works with the DSI and the Principal Statistician in the development and execution of the simulation plan based on design options and simulation specifications provided by DSI, SDD and study teams; and deliver simulation reports under the guidance from DSI. Participates in discussion sessions of EGP development and study design to ensure understanding of the clinical trial design options and collect design inputs from DSI, SDD and study team Works with the DSI and the Principal Statistician to develop and finalize simulation plan with detailed specifications and operating characteristics that enable the evaluation and selection of the optimal design options Executes simulation plan and summarizes results in outputs in presentation ready visualization Works with the DSI and the Principal Statistician to evaluate design options and form design recommendations and finalize simulation report Participates in sessions to present simulation results and recommendations to the product/study team Contributes to the development of simulation and modeling tools for the design center Supports the promotion of innovative designs and analysis methods by contributing to internal training sessions Basic Qualifications Doctoral degree in Statistics/Biostatistics or other subject with high statistical content OR Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date OR Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experienc Preferred Qualifications Doctorate in Statistics/Biostatistics with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical research Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia Proactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applications Knowledge of Bayesian statistics Extensive knowledge of simulation and modeling techniques Work well with both statistical colleagues and cross functional teams Good communication skills (written and oral) Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Senior Automation Engineer - RAJ Global leader in the Biotechnology industry is seeking a professional Automation Engineer for employment. As a member of the Engineering and Facilities Reliability Automation team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. Job Responsibilities include: Day-to-day operational shift support for process control applications utilizing Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). In-depth knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate must have experience in change control, quality deviations, corrective and preventative actions, and qualification practices. Lead technical root cause analysis, incident investigations, and troubleshooting of process control issues related to electrical, instrumentation and control systems for drug product and packaging systems. Three or more years combined experience with the following product platforms. Rockwell Automation FactoryTalk & ControlLogix PLC Platforms. GE Intellution iFiX SCADA systems Wonderware SCADA systems Day-to-day Operational Support 24 x 7 Onsite/On Call for Day to Day Operational Support Troubleshooting Support to Mfg. Operations Automation System Administration Continuous Improvement Data Integrity Assessments Automation System OS and HotFix assessments and rollout Automation Business Process Improvements Automation System Reliability & Life Cycle Management Daily Plant work center team meetings Preventative and corrective maintenance Automation System spare parts PPoF (Purposeful Presence on the Floor) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). Lead and support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and operating standards. Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in, and process change control requests per established SOP and processes. Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems. Design and testing of newly installed and currently installed automation-based process equipment. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs. Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Basic Qualifications Doctorate degree OR Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience Preferred Qualifications B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering. Strong control system automation background. Design, installation, programming and validation of automated processes is essential. 5 or more years combined experience with the following product platforms. Rockwell Automation FactoryTalk & ControlLogix PLC Platform. One or more years' experience leading a team as well as work self-directed. Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation. Knowledge of ASTM 2500, S88 and S95 techniques. - Batch processing a desired advantage. Strong leadership, technical writing, and communication/presentation skills are required. Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. Experience in developing automation strategies for New Product Introduction and New Technology Deployment. Preferred Experience using the following systems: Lyophilizer System, Building Management System and Filling systems for Syringe and Vials Testing and Inspection machines for devices Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System) Cleaning Systems (Autoclaves, Depyrogenation oven, COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer) Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Amgen is the world's leading biotechnology company. Nurtured on a foundation of strong values, Amgen is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind! Amgen's 10-12 week internship program offers meaningful project experiences that contribute to Amgen's mission of serving patients. This internship provides the opportunity for executive and social networking and community volunteering, while also providing competitive compensation and the opportunity to convert to a full-time position after graduation. The summer intern in Global Strategic Sourcing (GSS) will be assigned a project in Supplier Relationship Management or within one of GSS' five category sub-functions: Marketing & Sales, Research & Development, Operations & Manufacturing, Technology & Devices, or Corporate Services. Projects are timely and relevant, support Amgen's strategic and tactical goals, and provide exposure to the cross-functional nature of a full-time position. Past projects have included: Developing a valuation tool for delivery devices (Devices) Assessing risk/benefit of international research and development sourcing (R&D) Managing a reverse auction to source vehicles for sales fleet (Sales) Optimizing annual scopes of work with advertising agencies (Marketing) "Deep Dive" analytics on global travel spend (Corporate Services) Responsibilities typically include benchmarking, market research, spend analysis, business case development, negotiations, and developing key strategic recommendations to improve our sourcing and supplier management initiatives. Interns are given access to senior leadership and are encouraged to spend the summer participating in program activities and networking with staff across the organization. Limited relocation / housing will be provided for eligible candidates. Basic Qualifications Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older. Graduated with a Bachelor's Degree from an accredited college or university with a 3.0 minimum GPA or equivalent. Currently enrolled in a MBA program from an accredited college or university and successful completion of first year of school and with intent to complete the program in two years. Must not be employed at the time the internship starts. Preferred Qualifications Undergraduate GPA of 3.3 or higher Experience in performing sophisticated financial modeling Biotechnology, pharmaceutical, or health care industry experience Excellent analytical and problem-solving skills Strong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with all levels of management Strong leadership ability and a team player Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Job Summary The Compliance Manager, Business Process Management role is a global role within Amgen's R&D Quality organization. Reporting to the Senior Manager, Business Process Management, and based at Amgen's corporate headquarters in Thousand Oaks, California, the primary objective of the Business Process Management group is to provide leadership on Business Process Management methodology to ensure key R&D processes are effective, efficient and embedded into the Quality Management System (QMS) as well as integrated into Amgen's overall continuous improvement strategy. This role will provide Business Process Management expertise and Quality Management System leadership to the R&D organization through: Strengthening and advancing Amgen's R&D QMS Managing process identification and definition modeling projects and leading identification of end-to-end processes Designing and developing process modelling tools, methods and systems Defining key compliance and quality metrics for processes Contributing to targeted process reviews and process improvement efforts Implementing and ensuring adherence to Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN) Basic Qualifications Doctorate degree OR Master's degree and 3 years of Quality/Compliance/Process Management experience OR Bachelor's degree and 5 years of Quality/Compliance/Process Management experience OR Associate's degree and 10 years of Quality/Compliance/Process Management experience OR High school diploma / GED and 12 years of Quality/Compliance/Process Management experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelor's Degree with four years of quality, compliance and process/project management experience in the biopharmaceutical industry Advanced skills in Vision Experience using/maintaining Business Process Management Systems Working knowledge of global regulations impacting R&D activities Experience in QMS oversight and implementation Knowledge of process management and operational excellence systems, methods and tools Yellow or Green Belt certification Proven ability to lead, influence and facilitate cross functional teams Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Cambridge, MA, USA
Oct 20, 2019
Full time
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. The Neuroscience department at our Cambridge, Massachusetts location is looking for an undergraduate student interested in a 6 month Co-op placement. The Co-op internship position is focused on molecular biology and biochemistry in the field of neurodegenerative disease research. The emphasis of projects will be on understanding how immune cells within the central nervous system can be harnessed to modify disease pathology. The successful co-op will contribute directly to neuroimmunology-related projects in the lab that seek to discover new avenues for therapeutic development. This assignment involves working closely with staff scientists and project team to design and execute multi-day experiments in addition to data analysis. The Co-op will be challenged to learn and integrate elements of bioinformatics, laboratory automation (robotics), microscopy, mammalian cell culture, and transcriptomics to complete project goals. Highly motivated students interested in developing the fundamental skills needed for a career in bioscience research are encouraged to apply. Our lab combines the frontiers of genome CRISPR/Cas9 genome editing with a range of molecular techniques to understand both the fundamental and translational biology of neurodegenerative disease. Relocation in the form of a miscellaneous allowance will be provided for eligible candidates. Basic Qualifications Amgen requires that all individuals applying for an undergraduate internship or an undergraduate co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Preferred Qualifications Degree Concentration(s) in Biological, physical/material, mathematics, computer, and health science majors or related field with an interest in bioscience research Basic bioscience laboratory experience including familiarity with routine molecular biology procedures (e.g. mammalian cell culture, DNA purification, DNA vector construction, bacterial transformation, PCR, agarose gel electrophoresis) Understanding of biochemical techniques such as western blotting and SDS-PAGE Team player with excellent communication skills, written and verbal Proficiency in Excel, Word, PowerPoint and scientific graphic software Simple programming and experience with databases Strong desire to learn a variety of techniques and explore independent ideas related to neuroimmunology Attention to detail and focused persistence in working through problems that may not have clear solutions Only candidates who apply via will be considered. Please search for Keyword 83330. #LI-DNP Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Amgen is seeking a Senior Associate Information System (IS) Programmer/Analyst to join the Quality OIS - Lab Systems group. The incumbent will be responsible for designing and implementing applications within the Product Monitor & Test service and will play a key role in improving current lab application functionality as well as in incorporating new technologies under the challenge of a complex and fast-changing technology landscape. Specific Responsibilities are: Work as a developer to tackle application issues and continually improve existing application functionality Identify existing and new technology solutions to support business requirements. Research and evaluate technical solutions and capabilities like security, scalability, reliability, maintainability, etc. Design, develop, test and implement application functionality Code and perform unit and integration testing of software to ensure accurate and efficient execution and alignment to business and technical requirements Collaborate with business partners and business analysts to translate business requirements into technical requirements Write documentation to support application improvements. Assist with estimating level of effort and hours required for each phase of a project Ensure projects are completed on time and within budget Prepare and maintain communication materials like roadmaps, position papers, presentations, demos and socialize the materials with our business clients and partner IS services Deliver results in an environment consisting of diverse global and matrixed partners; including non-dedicated resources Effectively be an outstanding resource with the business, service partners, and vendors Travel: International and / or domestic travel up to 5% may be necessary Basic Qualifications: Master's degree Or Bachelor's degree and 2 years of Information Systems experience Or Associate's degree and 6 years of Information Systems experience Or High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications 1 plus years of experience working as programmer with the ability to quickly learn other programming languages. Knowledge or experience with laboratory information systems, lab execution systems and chromatography data systems. Experience working on visualization and front-end technologies like Spotfire, Tableau, etc. Programming experience in languages like Python, R, Java, etc Working knowledge of Amazon Web Service (AWS) technologies such as EMR, S3, and EC2. Background in data modeling, object-oriented programming and/or functional programming Understanding of Cloud Technologies (AWS, Azure, Google Cloud) Understanding of at least one RDBMS (Postgres, MySQL, MSSQL, Oracle, etc.) Experience working with various IT development techniques like Agile and DevOps Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Thousand Oaks, CA, USA
Oct 20, 2019
Full time
Amgen is seeking a Business Performance Senior Manager - Results Delivery Office at our corporate campus located in Thousand Oaks, California. The Senior Manager will report directly to the Vice President, Results Delivery Office (RDO). The Senior Manager will lead, or provide liaison support, for components of functional change initiative(s), drive improvement opportunities through the use of Amgen Full Potential (AFP) process and toolkit, develop approaches to improve productivity and implement comprehensive change strategies to transform the organization and enable it to adapt to business challenges. The Senior Manager will work to bring the transformation into cross-functional areas. The RDO is focused on supporting improved business performance, target achievement and strategic initiatives that are key to Amgen's future performance. Key Responsibilities of the Senior Manager will include: Leads Amgen's Full Potential Capability, Tool Support, Coaching and Application by developing strong skills in application and facilitation of AFP methodology and tools Acts as a resource for use of AFP tools and methodology to solve business problems Provides cross-functional initiative support and works with teams to solve business problems using the Amgen's Full Potential Methodology Guides teams in the AFP methodology, driving innovative transformational thinking, ensuring fair process, escalating issues, and ensuring high quality deliverables in line with the AFP process Provides valuation and validation via business case support for teams to value ideas, options and investments (validation of results realized, methodology used, and long term sustainability of improvements) Supports idea generation in functions to ensure a pipeline of ongoing projects and pending ideas to align with short and long term targets Provides tracking and reporting of project status as agreed upon by the results delivery office for corporate role up and review in addition to functional tracking as deemed necessary by the local functional leader Basic Qualifications: Doctorate degree and 2 years of Scientific and/or Operations and/or Business experience OR Master's degree and 4 years of Scientific and/or Operations and/or Business experience OR Bachelor's degree and 6 years of Scientific and/or Operations and/or Business experience OR Associate's degree and 10 years of Scientific and/or Operations and/or Business experience OR High school diploma / GED & 12 years of Scientific and/or Operations and/or Business experience Preferred Qualifications: 5+ years' of experience in Biotechnology / Pharmaceutical industry 6+ years' of cross-functional consulting, project management, and/or Liaison experience Experience at a top tier Management Consulting Firm Strong presence with Senior Executives Excellent oral and written communication skills, including ability to storyline and prepare executive-level discussion documents Excellent conceptual problem-solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution Strong quantitative and qualitative analytic skills Strong leadership skills with a demonstrated ability to influence different styles Experience as a member of a high performing team Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen Rhode Island, USA
Oct 20, 2019
Full time
Validation Engineer will lead the development and execution of Computer Validation and Data Integrity strategies as well as ensure Validation activities are performed in a consistent and controlled manner to support the manufacture of bulk pharmaceuticals. Responsibilities: Provide leadership and coordination of validation activities Develop/Update Validation Plans Ensure compliance to Part 11 and execute Data Integrity activities Develop and Execute validation protocols/reports Generate, review and approve validation Documents including: DT, FT/FTF, CRSIQ/OQ, RTM, protocols, reports, etc. Execute Operational Excellence Projects Ensure alignment with regulatory guidelines and industry standards SOP development, review and approval Provide Change Control Assessments Deviation/CAPA initiation/ownership Participate in quality risk assessments for automation and equipment (QRAES) Participate in internal and external audits Coordination of activities between Amgen teams (Manufacturing, F&E, Automation, QC, etc.) Basic Qualifications : Master's Degree OR Bachelor's Degree & 2 years of Validation or Engineering experience OR Associate's degree & 6 years of Validation or Engineering experience OR High school diploma/GED & 8 years of Validation or Engineering experience Preferred Qualifications : 5+ years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated. operations/engineering/manufacturing/quality environment Technical understanding of pharmaceutical/biotechnology unit operations. Direct validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, validation plans, protocols and reports. Experience in regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to validation of pharmaceutical or biopharmaceutical processes and data integrity. Strong skills in communication, presentation, organization, team development and leadership. Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, and biopharmaceutical processes. Ability to evaluate compliance issues and interact with regulatory inspectors. System knowledge and experience with Computerized Systems, Deviations, CAPA and Change Control processes. Excellent verbal and written communication skills. Ability to manage multiple complex tasks at one time. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.