Bristol-Myers Squibb Company

  • Bristol-Myers Squibb Corporate Headquarters 430 E. 29th Street, 14th Floor, New York, NY 10016
  • https://www.bms.com
Bristol-Myers Squibb Company Massachusetts, USA
May 20, 2019
Full time
Bristol-Myers Squibb is seeking a highly motivated individual to join a fast paced, cross functional QC chemistry/microbiology team, focused on delivery of STAT results to manufacturing operations. Responsibilities: - Performs routine testing and data review ofin-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment. - Performs routine assays such as UV-VIS Spectrometry, TOCsr, utility testing, endotoxin testing, and various HPLC methodologies. - Performs routine environmental monitoring and in-process testing in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components - Performs sample management including: sample receipt, sample tracking, aliquots preparation, and sample distribution. - Develops working knowledge of cGMP, learn specific job related SOPs and develops proficiency in laboratory techniques - Writes and revises SOPs for managerial review and approval. - Aids in troubleshooting equipment and methods. - Trains less experienced analysts on basic and some more complex test methods. - Works on a 12 hour (5AM to 5PM)rotating shift which includes every other weekend and some holidays Qualifications - Knowledge of science generally attained through studies resulting in a B.S. in chemical or biologicalsciences, a related discipline, or its equivalent is required. - 0-2 years of experience in a regulated microbiology or chemistry laboratory. Some relevant experience in a biologics QC lab preferred. - Knowledge of laboratory techniques such as pH, volumetric measurement and basic laboratory safety practices - Some understanding of regulatory standards - Excellent manual dexterity including proficiency in aseptic techniques. - Strong detail orientation with strong general laboratory and good organizational skills. - Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. - Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices. -Required to work every rotating weekends, some holidays, and during adverse weather conditions in support of manufacturing facility. Flexibility to work irregular hours and short notice overtime. - QCSTAT Associates will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned. - Associates should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure. - Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials
Bristol-Myers Squibb Company New Brunswick, NJ, USA
May 20, 2019
Full time
Candidates must have a Ph.D. in organic chemistry with 0 to 3 years of additional related research experience. Candidates must possess a strong background in the theory and practice of synthetic organic chemistry, possess excellent problem solving skills and demonstrate a thorough understanding of synthetic methods and reaction mechanisms. Candidates will have expertise in the purification and characterization of organic compounds (Chromatography and NMR, MS, IR spectroscopy). Good oral and written communication skills and a desire to work in a collaborative team environment are required. Responsibiilties: Responsible for route scouting and the design and implementation of safe, efficient and robust chemical processes for the synthesis of drug candidates with the overarching goal of gathering fundamental process knowledge, scaling and transitioning such processes to manufacturing. Qualifications: Candidates must have a Ph.D. in organic chemistry with 0 to 3 years of additional related research experience. Candidates must possess a strong background in the theory and practice of synthetic organic chemistry, possess excellent problem solving skills and demonstrate a thorough understanding of synthetic methods and reaction mechanisms. Candidates will have expertise in the purification and characterization of organic compounds (Chromatography and NMR, MS, IR spectroscopy). Good oral and written communication skills and a desire to work in a collaborative team environment are required.
Bristol-Myers Squibb Company Massachusetts, USA
May 19, 2019
Full time
Major Duties and Responsibilities Executes and/or Leads installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems. Provides Single Point of Contact (SPOC) on all validation activities for a specific manufacturing area (Production Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage environment. Assignment of SPOC to designated manufacturing area is based on demonstrated technical knowledge and experience with associated equipment/systems. Provides validation subject matter expertise (SME) and leads multi-function teams, advises operations on validation matters, and defends the associated validation testing and summary reports to regulatory agencies, with oversight from Validation management. Leads validation projects whose scope, regulatory visibility, schedule requirements, and complexity require involvement in establishing informed risk-based decisions and coordination with stakeholders, collaborators, and quality assurance. Executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. For novel projects, this individual works with Quality Assurance, consulting Validation management as needed, to establish appropriate validation methodologies. Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply. Leads projects while serving as an individual contributor of technical work and a point of contact for project stakeholders and cross-functional team members. Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies, with oversight from management. Maintains familiarity with BMS directives and industry guidelines on qualification/validation. Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes. Experience Required Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent. A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent. Direct experience with process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is required. Knowledge of distributed control systems and automation (GAMP) validation concepts suggested. A working understanding of six sigma and lean principles suggested. Demonstrated proficiency in project management, communication, and technical writing skills suggested. Possess the professionalism and technical competency required to directly support the department before our stakeholders, regulatory agencies, and management. Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment. Ability to handle difficult and unusual tasks, often using creative problem-solving. Demonstrated track record of developing and implementing logical and optimal plans to achieve objectives. Provides technical expertise to management and lower level professionals. Ability to sense, understand, and react to others emotions and recognize the impact of their emotions on your and other's performance and behaviors. A candidate for this position should: Exercise sound judgment in making decisions and recommendations within generally defined practices and policies without management review. May make decisions and take action on standard cases without management review. May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Acts as an advisor to subordinates and becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have significant financial implications or cause significant delays in schedules.
Bristol-Myers Squibb Company Massachusetts, USA
May 19, 2019
Full time
Duties and Responsibilities: Trains staff, monitors and performs testing of, in-process, release, and stability for Bulk Drug Substance and drug product samples in a cGMP environment. Develops methods and procedures, to ensure compliance with corporate policies and procedures. Reviews data obtained for compliance to specifications and reports abnormalities. Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results. Develops and maintain expertise in one or more test methods. Leads low risk laboratory investigations. Reviews and revises standard operating procedures as needed. Performs data analysis and trending for method transfers and process investigations. Assists in troubleshooting laboratory equipment and procedures, taking required corrective action. Back up to Lab manager/Supervisor Knowledge and Skills: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory. Operational knowledge of some or all of the following analytical methodologies: Appearance (color/clarity/visual particulates), Free Thiols, Protein Concentration, and particle analysis procedures (HIAC, Semi-quantitative ) Experience with LIMS and Smart lab computer applications a plus. Proficient in common computer software applications. Strong general laboratory and organizational skills, effective communication skills, both oral and written. Demonstrated ability to schedule and plan work for a team Strong attention to detail. Previous method transfer/validation experience a plus Operational Excellence experience Contacts: Direct daily interaction with all staff and management of Quality Control Chemistry. Regular interaction with other QC and QA functions in the context of assigned work. Occasional interaction with Quality employees from other sites for methods transfer and training. Working Conditions: Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may include night shift or weekend assignments. Decision Making: May work on assignments that are basic in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Exercises judgment within specifically defined practices and policies in selecting methods and techniques for obtaining solutions. Coordinates with higher level leads/supervisors on decisions, and applies appropriate notification to management as appropriate. Failure to obtain results or erroneous decisions or recommendations would typically result in minor program delays. Supervision: Work is performed under general direction. Independently determines and develops approach to solution. Work is reviewed upon completion for adequacy in meeting objectives. May receive assignments which have a partially defined process to complete the assignment. Specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly. Failure to obtain results or erroneous decisions or recommendations would typically result in minor program delays. Oversees and provides guidance to non-exempt staff as required in daily laboratory procedures. No formal supervisory responsibilities
Bristol-Myers Squibb Company New Brunswick, NJ, USA
May 19, 2019
Full time
The Manager Data Excellence, Supply Chain is integral to shaping and managing supply chain data systems, processes and people enabling best in class supply chain data quality, analytics and operational performance. Responsibilities include developing and optimizing pertinent data processes, and leveraging cross functional partnerships to achieve Data Excellence and Global Supply Chain objectives. Responsibilities: Enabling the Rapid Response system Enabling the Rapid Response system, an advance planning tool for routine and scenario planning, advances BMS' ability to supply patients Evaluating business data processes and SAP technical setup Establishing and executing corrective actions enabling data to support Rapid Response and associated processes Remediating data and establishing Data Quality sustainability Establish new sustain data governance for Rapid Response attributes Define audit approach for demand propagation impacts related to master data Interface with IT for new RR Dashboard requirement Support SCPL/SNP/PP on master data setup Provide training to Global Planning Support SAP S/4 upgrade implementation The SAP S/4 upgrade ensures BMS utilizes a current Enterprise Resource Planning (ERP) system which supports supply chain, manufacturing, quality, finance, order to cash, etc. Lead interface with sites on GTS UAT and implementation Support SAP S/4 Global SOPs change and impacts Conducting cross functional training Partnering with IT to address technical issues Manage supply chain data Ensures enterprise data design incorporates global and operationaldata requirements Facilitates sites rollouts advising on data infrastructure and business capabilities Define and manages Audit Reports to ensure compliance to global data standards. Establishes corrective actions based data quality audit results Process Standardization and Sustainability Active participant in data governance networks and or boards Manages continuous improvement program which identifies, optimizes and socializes new/change processes Responsible for managing specific data management training requirements for all business functions, maintain training schedule and conducts end user training Provide subject matter expertise to key business initiatives in data management, including best practices Collaborate with stakeholders to define a strategic vision in creating value for the company beyond current operational use Collaborates with data stewards to define and implement data strategy, policies, and controls to ensure the enterprise data is accurate, complete, secure and reliable Guide business partners and stakeholders to define data quality metrics and objectives Refine Data Excellence team key performance indicators to manage operations and drive improvements Proactively identify areas for data quality improvements and resolve data qualityissues Research industry and data management trends and recommend best practices for data management processes and procedures Managing and governing daily data activities and strategic data initiatives Promoting data quality and ensure data standard alignment and adherence Developing and implementing continuous system and process improvements Experience Required: 7 years of experience with supply chain and or enterprise data applications with 4 years in a data management role desired 3 years of experience working in a regulated industry, pharmaceutical industry desired Supply Chain experience, preferably in the pharmaceutical industry that engages business specific organizations, functions and business support systems (manufacturing, regulatory, commercial, quality etc.) Must be able to routinely make decisions, unsupervised, that may affect immediate operations and have a companywide effect Capable of negotiating and influencing without authority in complex, high impact situations Self-directed with the ability to work independently and/or within a team, have a strong work ethic and high attention to detail Advanced analytics experience accurately identifying and summarizing trends and patterns Proficient in Project management, leading cross functional teams, defining key milestones and objectives, coordinating resolution to challenges, and tracking progress Knowledge Required: Proficient data management governance knowledge to achieve high data quality as well as data management systems knowledge, ideally in the SAP toolset (ECC, MDM, MDG) Strong knowledge in assessing and operating with different organizational structures, operating cultures and effective work styles to achieve results in a changing environment Proficient knowledge and exposure to current Good Manufacturing Practices (cGMP), regulatory and environmental health and safety requirements Proficient with Microsoft Office applications and Visio Educational Requirements : Bachelor's Degree in Supply Chain, Information/Technology Management, Business, Industrial Engineer or equivalent Advanced degree, diploma or certification(APICS CSCP or CPIM) in Data or Supply Chain Management desirable
Bristol-Myers Squibb Company Princeton, NJ, USA
May 19, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. ROLE IMPERATIVES As a Next Generation Development Team (NGDT) Lead in Oncology, this leader is accountable to Oncology Development, R&D and Company Leadership for: (i) creating a vision, and defining the strategy and development plan for each exploratory asset within their portfolio, (ii) developing a set of objective criteria against which each asset advancing through the BMS Oncology Research pipeline will be evaluated to enable robust and rapid decision making; and (iii) ensuring that only high quality and differentiated assets enter the full development pipeline. The NGDT Leader will oversee a multi-disciplinary team typically responsible for multiple oncology development assets, with a focus on immuno-oncology, from later stage Discovery (DP3) through transition to Full Development. Strategy & Execution • Uses an understanding of disease biology in immunology and oncology, the early-stage drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area, regulatory, and market access) to create a vision, then design and execute effective exploratory development programs in support of the overall R&D portfolio goals. • Effectively engages cross company expertise and utilizes advisory groups and governance bodies (e.g., TPC, Oncology Development LT, PSC) to define, revise and champion asset development strategies and implementation plans. • Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving toward delivering key data and interpretation essential for robust and rapid decision making on assigned projects. • Delivers high quality assets to Full Development which have the potential for a competitive profile to address the unmet medical needs of patients and to provide favorable shareholder return. • Ensures the process and output of the team meets established program standards (per PD&C Process expectations, within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline development and enable continuous improvements without compromising quality. • Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities, and clearly communicates program risks, implications of changes in the competitive landscape and progress toward key milestones. Leadership & Matrix Alignment • Forward looking, objective matrix leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view. • Experience/judgment to efficiently integrate information from team members/key advisors to facilitate making rapid and objective decisions. • Sets goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the BMS matrix to accomplish the asset development plan. • Oversees relevant sub-teams and ensures clear goals and performance standards are in place, provides feedback and coaching, appropriately delegates responsibilities, and holds sub-team leaders accountable for key deliverables. • Builds, proactively manages, and professionally develops a high performing team with diverse perspectives • Builds productive peer to peer relationships with functional heads of all groups that interact with the NGDT to ensure optimal functional area cooperation and resource support needed for optimal delivery on NGDT goals and overall portfolio priorities. ESSENTIAL LEADERSHIP BEHAVIORS Strategy and Vision Be a strategic thinker who is able to articulate vision in a rapidly changing environment and in concert with enterprise strategy. Demonstrate strong business acumen and problem solving skills. Able to flex well between enterprise and functional orientation. Able to effectively manage complexity and competing priorities. Leadership with Expertise While expertise is critical when leading, it is about wisdom not technical/scientific expertise at this level of leadership. Ability to rise above the technical elements and focus more on the insights and implications. Success is more a function of ability to create followership and bring people along vs. expertise and knowledge in specific subject areas. External Focus/Customer Orientation Develops and maintains relationships with key external stakeholders, including thought leaders, advocacy and disease organizations. Team & Organization Leadership Proven leadership experience and success with building and developing teams. Ability to attract and retain top talent. Committed to talent development and diversification. Inspirational and embodies BMS Behaviors. Leads by example. Is an inclusive leader. Leads with fairness but high expectations on accountability. Judgment & Business Ethics Demonstrates impeccable business ethics. Adheres to an appropriate and effective set of core values and beliefs, and acts in line with those values. Operates with independence, and possesses the confidence and fortitude to take principled positions. Impact & Influence Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly demonstrated ability to work across the critical interfaces whether within RD or across the enterprise. Able to cut across silos/straddle boundaries. Excellent communication and presentation skills, high level negotiation skills and the ability to resolve conflict in a constructive manner. Communicates effectively at all levels of the organization, including senior management. Acts as a credible, influential, and respected spokesperson for R&D - whether internally or externally Results oriented Delivers results with a focus on efficiency, effectiveness and robust decision making. Focuses not only on what is to be achieved but how it is achieved. Has an eye for detail, and is able to stay focused on the big picture. Track record of consistent strong performance over time Entrepreneurial Willingness to take educated risks in moving the business needs forward. Questions how it can be done better. Willing to break traditions and test boundaries - tests the status quo. Is flexible and nimble, able to adapt to changing environmental conditions. Demonstrates courage and persistence. DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE • MD , PhD, DVM, PharmD, MBA, or equivalent advanced degree of relevance • Experienced drug developer with 10+ years' experience in the drug development process, with particular in-depth know how and experience in the exploratory development space. • Deep understanding of the role of basic biology, pharmaceutical optimization, and translational medicine in exploratory development • Strong understanding of relevant regulatory health authority expectations and regulations for drug development, with a focus on exploratory development but with an understanding of implications toward full development • Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, etc. • Demonstrated scientific acumen and mechanistic understanding of disease biology in immunology and oncology • Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry • Demonstrated ability to execute Development Plans which have global perspective and focus on product differentiation, including opportunities for data driven acceleration • Demonstrated ability to objectively assess complex but relatively sparse data sets and make informed decisions and take action in the face of uncertainty. • Experience in successfully managing and leading high performing, cross-functional matrix teams or complex multi-functional organizations • Ability to effectively and seamlessly multitask across multiple exploratory development assets. • Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries
Bristol-Myers Squibb Company Syracuse, NY, USA
May 17, 2019
Full time
Document Control Coordinator responsible for managing and executing the initiation, processing, routing, distribution and archiving of cGMP records in accordance with internal and external regulations, policies, and procedures utilizing appropriate electronic systems. Duties/Responsibilities: Perform all routine activities associated with the document change management system. Support the revision and creation of GMP documentation through the document change process. This includes, but is not limited to, performing routing, document processing, and formatting of documents. Perform all routine activities associated with manufacturing batch record issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks which will require work inside classified manufacturing areas. Assist with the records management program, including interim and archive activities as well as managing shipments to Iron Mountain. Manage the retention of documentation in accordance with records retention schedules in conjunction with legal hold notices Perform document storage room activities such as filing, organization, barcoding in RMS and escorting personnel into the room. QUALIFICATIONS Specific Knowledge, Skills, Abilities, etc: This position requires demonstration of excellent organizational skills and attention to detail. Personnel must demonstrate flexibility and capability of multitasking, as well as demonstrate excellent oral and written communication skills and excellent computer competence. Effective interaction with all contacts is required. Personnel must also exercise sound judgment in assuring compliance with Regulations. Self-directed with ability to take initiative and follow through to completion on commitments. Ability to create effective change in a team based collaborative environment. Education/Experience/ Licenses/Certifications: High School diploma required, a college degree preferred with a minimum of 2 years experience. Controlled documentation experience preferred. GMP experience preferred. Physical Demands: Primarily an office based position with filing requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists and reaching. Must be able to lift up to 20 lbs. Work Environment: Primarily an office based position with entry into manufacturing and warehouse facilities within classified areas requiring appropriate levels of PPE. May also require entry into laboratory spaces that require appropriate levels of PPE. Entry into manufacturing area will require special gowning including removal of all makeup, jewelry and nail polish. Only plain wedding bands are allowed. Travel: This position requires up to 0% of travel Supervisory Responsibilities: N/A
Bristol-Myers Squibb Company Redwood City, CA, USA
May 15, 2019
Full time
Research Associate 3, Protein Engineering Job Description: We are seeking a skilled and enthusiastic protein engineer at a Research Associate level to join the Protein Engineering Group. The candidate will be expected to work on a variety of protein engineering projects to optimize and generate differentiated antibody therapeutic leads. Specific Responsibilities: • Participate in protein engineering efforts to optimize variable and constant domains of antibodies. • Protein expression of various antigens and antibodies in multiple expression systems (mammalian, insect, yeast, and E. coli) • Protein purification utilizing variety of methods (affinity, ion-exchange, hydrophobic, size-exclusion chromatography) • Perform complex experiments with strong attention to detail and documentation. • Excellent written and oral skills are necessary. • Accomplish goals under project team time lines. Requirements: • BS degree with 5+ years of industry experience or MS degree with 2+ years of industry experience. The degree should be in Biochemistry, Biophysics, Molecular and Cell Biology, Structural biology, or similar field. • Experience in generation and characterization of protein and antibody variants. • Extensive experience and knowledge in molecular biology, protein expression, purification, and characterization. • Excellent time management and organizational skills. • Experience with display technologies a plus • Ability to work in a multidisciplinary biologics discovery team.
Bristol-Myers Squibb Company Hopewell, NJ 08525, USA
May 15, 2019
Summary This role will report to the Director of Quality Clinical Compliance and Risk Management who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Each Risk Management Lead will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function. Responsibilities will include Collaborate with the study teams and help build Quality by Design from protocol development and study startup, to database lock, and through protocol amendments, to ensure appropriate cross-functional coordination of risk assessment and management throughout the duration of Clinical Trials. Own the Risk Assessment and Categorization Tool (RACT) and work closely with all functions involved to assure alignment on the Quality Threshold Limits (QTLs) and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities. During the identification of potential clinical operations external partners (Contract Research Organizations, specialty labs, etc), work on the technical assessment as part of the due diligence process, to determine Quality and Compliance capabilities and health of the Quality Management System of the potential partner. Work closely with the Clinical Trial Planning and Alliance Management team as well as the Global Quality organization to develop appropriate Quality Agreements and Quality Oversight management plans with partners. Provide day-to-day vendor oversight and ensure appropriate documentation of such. Perform ongoing assessment of the effectiveness of the Risk Mitigation activities identified in the RACT and escalate to the right level of Governance as needed. Collaborate with Regional Clinical Compliance teams to support Global Clinical Operations study teams to be inspection ready at all times. Coordinate Inspection Preparedness efforts and support sponsor audits and inspections in partnership with Global Quality. Serve as Corrective Action Preventive Action (CAPA) lead and support individual CAPA owners to conduct root cause analyses, develop mitigation plans, and implement CAPAs within prescribed deadlines. Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans. Work with management and Global Quality to foster a cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset. Qualifications A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required. Robust understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions. Experience with the RACT and Risk-Based Monitoring principles, experience with eTMF, Veeva systems, CTMS (Seibel) and other quality systems is required. Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner. Experience in Project Management is a plus in the context of Inspection Preparedness. Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills. The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.
Bristol-Myers Squibb Company Kansas City, MO, USA
May 13, 2019
The FMS role embodies our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice and drive appropriate adoption of BMS medicines. The FMS role is field-based and it is anticipated that an FMS will spend a minimum of 60-70% of their time in the field with external customers. The primary role of the FMS is to develop relationships and maintain contacts with research focused Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management, treatment landscape, and BMS products in a fair and balanced way and includes appropriate clinical and value related discussions. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. Note: Only Hematology FMSs are trained on HEOR and access resources. The FMS will use various channels for interactions (1:1, group presentation; remote, etc). Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TL/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TL/HCPs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Adopt institution/account planning approach and contribute to cross-functional institution/account plans. • Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment). Support Clinical Trial Activities Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Clinical Operations (GCO) and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GCO. Actively support CRO sponsored studies as agreed with home office medical and GCO and as defined by the study scope document. Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GCO. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Required Experience MD, PharmD, DNP, or PhD, with experience in a specific Disease Area or with a broad medical background (preferred) OR Science Graduate with relevant pharmaceutical experience A minimum of 2 years working in a clinical or pharmaceutical environment. Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Travel required Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Core Behaviors Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
Bristol-Myers Squibb Company Princeton, NJ, USA
May 12, 2019
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. ROLE IMPERATIVES As a Next Generation Development Team (NGDT) Lead in Oncology, this leader is accountable to Oncology Development, R&D and Company Leadership for: (i) creating a vision, and defining the strategy and development plan for each exploratory asset within their portfolio, (ii) developing a set of objective criteria against which each asset advancing through the BMS Oncology Research pipeline will be evaluated to enable robust and rapid decision making; and (iii) ensuring that only high quality and differentiated assets enter the full development pipeline. The NGDT Leader will oversee a multi-disciplinary team typically responsible for multiple oncology development assets, with a focus on immuno-oncology, from later stage Discovery (DP3) through transition to Full Development. Strategy & Execution ? Uses an understanding of disease biology in immunology and oncology, the early-stage drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area, regulatory, and market access) to create a vision, then design and execute effective exploratory development programs in support of the overall R&D portfolio goals. ? Effectively engages cross company expertise and utilizes advisory groups and governance bodies (e.g., TPC, Oncology Development LT, PSC) to define, revise and champion asset development strategies and implementation plans. ? Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving toward delivering key data and interpretation essential for robust and rapid decision making on assigned projects. ? Delivers high quality assets to Full Development which have the potential for a competitive profile to address the unmet medical needs of patients and to provide favorable shareholder return. ? Ensures the process and output of the team meets established program standards (per PD&C Process expectations, within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline development and enable continuous improvements without compromising quality. ? Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities, and clearly communicates program risks, implications of changes in the competitive landscape and progress toward key milestones. Leadership & Matrix Alignment ? Forward looking, objective matrix leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view. ? Experience/judgment to efficiently integrate information from team members/key advisors to facilitate making rapid and objective decisions. ? Sets goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the BMS matrix to accomplish the asset development plan. ? Oversees relevant sub-teams and ensures clear goals and performance standards are in place, provides feedback and coaching, appropriately delegates responsibilities, and holds sub-team leaders accountable for key deliverables. ? Builds, proactively manages, and professionally develops a high performing team with diverse perspectives ? Builds productive peer to peer relationships with functional heads of all groups that interact with the NGDT to ensure optimal functional area cooperation and resource support needed for optimal delivery on NGDT goals and overall portfolio priorities. ESSENTIAL LEADERSHIP BEHAVIORS Strategy and Vision Be a strategic thinker who is able to articulate vision in a rapidly changing environment and in concert with enterprise strategy. Demonstrate strong business acumen and problem solving skills. Able to flex well between enterprise and functional orientation. Able to effectively manage complexity and competing priorities. Leadership with Expertise While expertise is critical when leading, it is about wisdom not technical/scientific expertise at this level of leadership. Ability to rise above the technical elements and focus more on the insights and implications. Success is more a function of ability to create followership and bring people along vs. expertise and knowledge in specific subject areas. External Focus/Customer Orientation Develops and maintains relationships with key external stakeholders, including thought leaders, advocacy and disease organizations. Team & Organization Leadership Proven leadership experience and success with building and developing teams. Ability to attract and retain top talent. Committed to talent development and diversification. Inspirational and embodies BMS Behaviors. Leads by example. Is an inclusive leader. Leads with fairness but high expectations on accountability. Judgment & Business Ethics Demonstrates impeccable business ethics. Adheres to an appropriate and effective set of core values and beliefs, and acts in line with those values. Operates with independence, and possesses the confidence and fortitude to take principled positions. Impact & Influence Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly demonstrated ability to work across the critical interfaces whether within RD or across the enterprise. Able to cut across silos/straddle boundaries. Excellent communication and presentation skills, high level negotiation skills and the ability to resolve conflict in a constructive manner. Communicates effectively at all levels of the organization, including senior management. Acts as a credible, influential, and respected spokesperson for R&D - whether internally or externally Results oriented Delivers results with a focus on efficiency, effectiveness and robust decision making. Focuses not only on what is to be achieved but how it is achieved. Has an eye for detail, and is able to stay focused on the big picture. Track record of consistent strong performance over time Entrepreneurial Willingness to take educated risks in moving the business needs forward. Questions how it can be done better. Willing to break traditions and test boundaries - tests the status quo. Is flexible and nimble, able to adapt to changing environmental conditions. Demonstrates courage and persistence. DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE ? MD , PhD, DVM, PharmD, MBA, or equivalent advanced degree of relevance ? Experienced drug developer with 10+ years' experience in the drug development process, with particular in-depth know how and experience in the exploratory development space. ? Deep understanding of the role of basic biology, pharmaceutical optimization, and translational medicine in exploratory development ? Strong understanding of relevant regulatory health authority expectations and regulations for drug development, with a focus on exploratory development but with an understanding of implications toward full development ? Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, etc. ? Demonstrated scientific acumen and mechanistic understanding of disease biology in immunology and oncology ? Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry ? Demonstrated ability to execute Development Plans which have global perspective and focus on product differentiation, including opportunities for data driven acceleration ? Demonstrated ability to objectively assess complex but relatively sparse data sets and make informed decisions and take action in the face of uncertainty. ? Experience in successfully managing and leading high performing, cross-functional matrix teams or complex multi-functional organizations ? Ability to effectively and seamlessly multitask across multiple exploratory development assets. ? Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries
Bristol-Myers Squibb Company Massachusetts, USA
May 12, 2019
Full time
Reporting to QC Technical Support Manager, the QCTS Associate Scientist will lead and support the method validation, transfer, troubleshooting and technical documentation for cGMP biologics commercial and clinical manufacturing analytical laboratories. This role will act as a Subject Matter Expert (SME) for bioanalytical methods such as cell based bioassays, ELISA, PCR assays, and provide technical support to QC Operations. Major Responsibilities include: Participate in multi-site method transfer and validation projects for Devens QC: Author and review validation, transfer protocols and reports; execute validation and transfer independently; summarize, review and approve data; troubleshoot the failures and deviations and make recommendation on corrective actions. Provide support to QC Operation as method SME: develop training approach, training documents and provide training for new methods; support QC method troubleshooting, lab investigations, OOSs, OOTs, CAPAs, Data Integrity initiatives; Assist in method performance review, able to recognize anomalous trends or results and make recommendation on method life cycle management and improvement; work closely with Analytical Science and Technology on developing and implementing innovative techniques into QC Operations. Provide support to QC department on equipment: serve as instrument SME related to Bioassay and ELISA assays; work with instrument qualification team to assist in equipment IOPQs and troubleshooting with internal teams and external vendors; support new versions of software implementation including method impact assessment, validations and comparability studies. Support health authority inspections such as FDA, EMA, and other health agencies. Qualifications/Requirements: BS / MS, preferably in Analytical Chemistry, Bioanalytical or Biology field. Minimum of4 years (MS) /6 years (BS) relevant experience in Biologics or biopharmaceutical cGLP or cGMP lab. Knowledge in cGMP regulations as referenced in The Code of Federal Regulations. Strong background and demonstrated effectiveness with method validation transfer for biologics methodology. Strong problem solving ability, interpersonal, oral and written communication skills. Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals. Familiar with data analysis software such as PLA, SAS, Softmax and QC laboratory systems such as electronic notebooks (ELN) and LIMS is desirable.
Bristol-Myers Squibb Company Tampa, FL, USA
May 12, 2019
Full time
PDLs embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice, and drive appropriate adoption of BMS medicines. The PDL role is a field-based role focused on Hematology and Oncology. It is anticipated that a PDL will spend a minimum of 60-70% of their time in the field with external customers. The primary role of PDLs is to develop and maintain contacts with Pathology and Laboratory Leaders within their assigned territory. The purpose of interactions is to ensure patients have access to BMS medicines, to ensure the safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by the stakeholders, and to facilitate internal and external understanding of oncology diagnostics. The scientific dialogue focuses on scientific/clinical information around disease management, BMS products and relevantbiomarkers/diagnostics,in a fair and balanced way. External Environment and Customer Focus Develop and maintain interactions with Pathology and Laboratory Leaders, within a given geography to answer scientific, unsolicited product andbiomarker/diagnostic-relatedquestions. PDLs will use various channels for interactions (1:1, group presentation; remote connections, etc.). Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical and diagnostic landscape by meeting with Pathology and Diagnostic Leaders to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product/diagnostic specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support by presenting unbiased scientific and clinical data. Required Experience Advanced clinical science degree: PhD or MD preferred. Pharmacists, and advanced practice nurses with similar medical experience may be considered. A minimum of 2 years working in a laboratory, clinical or pharmaceutical environment. Knowledge Desired Oncology disease area knowledge and an understanding of scientific publications Diagnostic experience strongly preferred Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Excellent English language skills, spoken and written Travel required (varies by geography) Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research orhealthcare/laboratoryprofessionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Must live within assigned territory. Must have ability to travel up to 70% and hold a valid driver's license.
Bristol-Myers Squibb Company Kansas City, MO, USA
May 12, 2019
Full time
The FMS role embodies our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice and drive appropriate adoption of BMS medicines. The FMS role is field-based and it is anticipated that an FMS will spend a minimum of 60-70% of their time in the field with external customers. The primary role of the FMS is to develop relationships and maintain contacts with research focused Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management, treatment landscape, and BMS products in a fair and balanced way and includes appropriate clinical and value related discussions. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. Note: Only Hematology FMSs are trained on HEOR and access resources. The FMS will use various channels for interactions (1:1, group presentation; remote, etc). Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TL/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TL/HCPs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Adopt institution/account planning approach and contribute to cross-functional institution/account plans. • Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment). Support Clinical Trial Activities Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Clinical Operations (GCO) and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GCO. Actively support CRO sponsored studies as agreed with home office medical and GCO and as defined by the study scope document. Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GCO. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Required Experience MD, PharmD, DNP, or PhD, with experience in a specific Disease Area or with a broad medical background (preferred) OR Science Graduate with relevant pharmaceutical experience A minimum of 2 years working in a clinical or pharmaceutical environment. Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Travel required Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Core Behaviors Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
Bristol-Myers Squibb Company Princeton, NJ, USA
May 10, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The successful candidate will be responsible for running an independent program in the discovery of novel treatments for diseases having disregulated immunity, primarily autoimmunity but also including tumor immunology. Responsibilities include investigating the cellular immunology and pharmacology of targets and agents in relation to human disease. This investigator will work independently and provide oversight of the design, execution and interpretation of biochemical and cellular assays, as well as in vivo pharmacology studies, in support of our Discovery efforts to identify and nominate agents for clinical development. This role requires a close working relationship with other scientists within a multi-disciplinary drug discovery team. Qualifications: Ph.D. in Cellular Immunology or a related field, with 3-5 years of postgraduate research. Experience in immunology-based drug discovery in an industry setting (pharma or biotech) would be a great advantage, but not required. Knowledge of adaptive and innate cellular immunology and immune tolerance including, but not restricted to, the role of T and B lymphocytes, innate lymphoid cells, and dendritic cells in the regulation of immunity is a must. This position requires both a strong understanding of how disregulated immunity drives human disease pathobiology, as well as expertise in functional cell-based assays such as T-cell, B-cell and dendritic cell differentiation, proliferation, and function, as well as receptor binding and occupancy, and cellular signaling using appropriate biochemical, cellular and pharmacological techniques. Extensive experience with aseptic isolation and culture of rodent and human primary cells and FACS-based characterization of the same is also a requirement. Familiarity in the analysis of genomics-based studies would also be of value. Excellent communication, collaboration and leadership skills, along with a strong publication record in peer-reviewed journals, are considered key qualifications. Experience in supervisory responsibility would be preferred, but not required.
Bristol-Myers Squibb Company Redwood City, CA, USA
May 10, 2019
Full time
We are seeking a skilled protein chemist at the Research Scientist or Research Investigator level (based on experience) to join the expression and purification group. The candidate will be expected to work on a variety of projects to purify antibodies from multiple species and heterologous expression systems. Specific Responsibilities Purify proteins using variety of systems (affinity, ion exchange, size exclusion, etc.). Purify proteins using multiple purification platforms (i.e. AKTA Avant, etc.). Analyze proteins using standard protein characterization methods (SDS-PAGE/CE-SDS, SEC-MALLS, endotoxin, etc.). Perform experiments with strong attention to detail and documentation. Excellent written and oral skills are necessary. Accomplish goals under project team time lines. Requirements Ph.D. with postdoctoral experience or MS degree with 5+ years of industry experience required. The degree should be in Biochemistry, Biophysics, Molecular and Cell Biology, or a similar field. Experience in generation and characterization of high quality proteins for immunizations, crystallography, or other uses is required. The ideal candidate should have demonstrated independence in experimental design, execution, data analysis, and troubleshooting. Strong expertise in antibody purification and characterization for in vitro and in vivo uses is highly preferred. Experience in automated purification is highly preferred. Experience and knowledge of molecular biology and expression is preferred. Experience with characterization of antibodies for development attributes and familiarity with downstream development is a plus. Excellent interpersonal skills are required with the ability to interact effectively with people, both internally in a multidisciplinary biologics discovery team and externally across the organization.
Bristol-Myers Squibb Company Princeton, NJ, USA
May 10, 2019
Full time
The BMS Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. In BMS Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate use of our medicines. By bridging clinical development with clinical practice, the Medical organization plays a valuable and unique role in helping to unlock the full potential of our scientific and medical innovation. Critical Responsibilities Collaborate with Melanoma Development, Early Asset Development, and Worldwide Medical teams in the development of the long-term melanoma tumor strategy Identify key data gaps and lead the review, approval, and timely execution of investigator initiated research Partner with US Commercial & Access organizations to integrate medical perspectives into the commercialization process Partner with the Health Economics and Outcomes Research (HEOR) team to generate impactful real-world and health economic data Critically review BMS publications and field medical materials to ensure effective pull-through of the medical strategy Develop and maintain strong relationships with external thought leaders and investigators Act as a disease state and therapeutic expert both internally and externally Qualifications Advanced scientific degree (MD, PhD, PharmD) Prior pharmaceutical industry experience in medical affairs or clinical research is desirable Familiarity with all phases of oncology drug development is desirable, including clinical development, regulatory and life cycle management Therapeutic area & clinical expertise is desirable Experience in leading complex projects and diverse, high performing teams Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders Demonstrated ability to execute and deliver results in a deadline-driven environment Clear and effective verbal & written communication skills Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D
Bristol-Myers Squibb Company Hopewell, NJ 08525, USA
May 10, 2019
Full time
Summary This role will report to the Director of Quality Clinical Compliance and Risk Management who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Each Risk Management Lead will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function. Responsibilities will include Collaborate with the study teams and help build Quality by Design from protocol development and study startup, to database lock, and through protocol amendments, to ensure appropriate cross-functional coordination of risk assessment and management throughout the duration of Clinical Trials. Own the Risk Assessment and Categorization Tool (RACT) and work closely with all functions involved to assure alignment on the Quality Threshold Limits (QTLs) and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities. During the identification of potential clinical operations external partners (Contract Research Organizations, specialty labs, etc), work on the technical assessment as part of the due diligence process, to determine Quality and Compliance capabilities and health of the Quality Management System of the potential partner. Work closely with the Clinical Trial Planning and Alliance Management team as well as the Global Quality organization to develop appropriate Quality Agreements and Quality Oversight management plans with partners. Provide day-to-day vendor oversight and ensure appropriate documentation of such. Perform ongoing assessment of the effectiveness of the Risk Mitigation activities identified in the RACT and escalate to the right level of Governance as needed. Collaborate with Regional Clinical Compliance teams to support Global Clinical Operations study teams to be inspection ready at all times. Coordinate Inspection Preparedness efforts and support sponsor audits and inspections in partnership with Global Quality. Serve as Corrective Action Preventive Action (CAPA) lead and support individual CAPA owners to conduct root cause analyses, develop mitigation plans, and implement CAPAs within prescribed deadlines. Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans. Work with management and Global Quality to foster a cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset. Qualifications A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required. Robust understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions. Experience with the RACT and Risk-Based Monitoring principles, experience with eTMF, Veeva systems, CTMS (Seibel) and other quality systems is required. Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner. Experience in Project Management is a plus in the context of Inspection Preparedness. Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills. The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.
Bristol-Myers Squibb Company Ayer, MA, USA
May 10, 2019
Reporting to QC Technical Support Manager, the QCTS Associate Scientist will lead and support the method validation, transfer, troubleshooting and technical documentation for cGMP biologics commercial and clinical manufacturing analytical laboratories. This role will act as a Subject Matter Expert (SME) for bioanalytical methods such as cell based bioassays, ELISA, PCR assays, and provide technical support to QC Operations. Major Responsibilities include: Participate in multi-site method transfer and validation projects for Devens QC: Author and review validation, transfer protocols and reports; execute validation and transfer independently; summarize, review and approve data; troubleshoot the failures and deviations and make recommendation on corrective actions. Provide support to QC Operation as method SME: develop training approach, training documents and provide training for new methods; support QC method troubleshooting, lab investigations, OOSs, OOTs, CAPAs, Data Integrity initiatives; Assist in method performance review, able to recognize anomalous trends or results and make recommendation on method life cycle management and improvement; work closely with Analytical Science and Technology on developing and implementing innovative techniques into QC Operations. Provide support to QC department on equipment: serve as instrument SME related to Bioassay and ELISA assays; work with instrument qualification team to assist in equipment IOPQs and troubleshooting with internal teams and external vendors; support new versions of software implementation including method impact assessment, validations and comparability studies. Support health authority inspections such as FDA, EMA, and other health agencies. Qualifications/Requirements: BS / MS, preferably in Analytical Chemistry, Bioanalytical or Biology field. Minimum of4 years (MS) /6 years (BS) relevant experience in Biologics or biopharmaceutical cGLP or cGMP lab. Knowledge in cGMP regulations as referenced in The Code of Federal Regulations. Strong background and demonstrated effectiveness with method validation transfer for biologics methodology. Strong problem solving ability, interpersonal, oral and written communication skills. Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals. Familiar with data analysis software such as PLA, SAS, Softmax and QC laboratory systems such as electronic notebooks (ELN) and LIMS is desirable.
Bristol-Myers Squibb Company Massachusetts, USA
May 09, 2019
Full time
Lead Supply Chain Quality Systems Lead investigation teams for Supply Chain department including management of resulting CAPAs & SOP revisions Supply Chain Dept Change Control gatekeeper: Facilitate Supply Chain Leadership Team (LT) review to assess change control impact & change actions. Create pre/post action items in Trackwise following LT review Manage the periodic review program for the Supply Chain Dept; work with functional areas to complete assessments. Revise SOPs with focused revision scope Provide support during regulatory agency and internal inspections. Coordinate responses to regulatory, internal and external compliance requirements with Supply Chain supervisors and managers Partner with Supply Chain leadership and relevant departments to manage the Supply Chain training curricula (Dept Training program owner). Deliver training resulting from CAPAs, procedure revisions,& other requirements Manage Supply Chain Quality Systems Portfolio Represent the Supply Chain department at cross-functional huddles (i.e. investigation, change control & CAPA). Effectively & efficiently source information on item status from the Supply Chain team & hold team members accountable. Facilitate resolution of items at risk of on-time completion; escalate unresolved risks for on-time completion Manage the Supply Chain Dept portfolio of work for on-time completion of investigations, CAPA/tasks, change control actions & periodic reviews (metrics) Operational Excellence & Project Leadership Lead (cross-functionally) or represent Supply Chain on Priority 2 (site level cross functional) and/or Priority 3 (Dept level) projects. May represent the Devens site Supply Chain on Priority 1 (network level) projects. Support & participate in the site Operational Excellence program. Drive opportunities & projects for continuous improvement Participate in site safety initiatives to improve safety culture Influence & Mentor Communicate with cross-functional leaders to inside and outside of Supply Chain to drive successful outcomes for the site and functional business unit Act as a mentor to group members for quality and compliance tasks. Ensure compliance across all areas of Supply Chain including verification of followed procedures through routine compliance checks and documentation review Knowledge &Skill Knowledge generally gained by course of study for a Bachelors degree or its equivalent A minimum of 2-4 years of (combined) experience in a regulated manufacturing environment (Warehouse, Quality, etc)function with experience in supply chain processes, investigation management, process mapping and regulatory knowledge Project work is required with the ability to collaborate cross-functionally with other groups and levels Critical skills include a high degree of initiative, strong problem solving skills & attention to detail Excellent communications and computer skills with a demonstrated proficiency with MS Access, Word, Excel, PowerPoint & Project Ability to work independently and participate in project teams. Able to communicate will all levels of Management, develop successful working relationships, and possess an ability to influence site team members. Able to communicate effectively and develop successful working relationships Experience with SAP and TrackWise desirable