Bachem

Bachem Torrance, CA, USA
Oct 20, 2019
Full time
Your Responsibilities The Building Services Technician supports the Facilities, Maintenance, and other teams as needed to ensure manufacturing is performed according to schedule and quality demands. Job responsibilities include, but are not limited to, basic maintenance tasks for facilities and equipment, preparing Your Tasks Follow Standard Operating Procedures (SOPs) and approved directions to perform basic maintenance tasks on facilities and equipment Follow SOPs and approved directions to clean glassware and equipment used in GMP processes Maintain cleaning logs and maintenance logs Maintain stock of parts, supplies, materials, and tools within areas of responsibility Assist in equipment calibration program Follow approved GMP manufacturing directions such as Standard Operation Procedures, Standard Test Procedures, and related activities Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Follow and maintain Good Documentation Practices. Investigate any process deviations, write process deviation reports and initiate document change requests Your Profile High school diploma/GED or ability to obtain one in 12 months. 1-3 years glass washing and/or facilities or equipment maintenance Ability to safely work with hazardous materials, chemicals, and machines Ability to understand written and verbal instructions in English and communicate effectively in English Flexibility of working hours based on business needs, may include some nights and occasional weekends Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Oct 20, 2019
Full time
The Research Sales Representative will be responsible for selling the company's products and services by contacting prospective and established customers. The Research Sales Representative will follow up on leads and establish close customer contacts to promote the company's products to select accounts as designated by Sales Management. Your Tasks • Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails • Contact prospective customers to uncover sales leads and pursue to completion • Present applicable company capabilities as benefits to prospective customers • Maintain sales program to meet Sales Budget • Provide information to customers as it pertains to available services, prices and new products • Distill customer requirements and qualify project leads before presenting to operational functions • Prepare sales proposals and present offer to customers • Meet established company sales quota by obtaining and renewing orders • Monitor competitive activity and trends within the established territory • Process customer orders as required • Maintain and update customer accounts and contact information as well as relevant communications in the ERP and CRM systems • Act as liaison between customer contacts and operations personnel • Answer inbound customer calls and manage customer inquiries • Gather and communicate relevant market information to Sales Management • Follow up on customer concerns and requests for information and new customer opportunities Your Profile Required: • BS degree in science related field • 1-2 years proven work experience as Sales representative or Customer Service representative • Experience working with ERP and CRM systems • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues • Detail oriented with the ability to troubleshoot and resolve problems • Ability to work independently and manage one's time • Communicate effectively and ability to function well in a team environment Preferred: • Advanced Degree • 3-5 Years Sales experience • Pharmaceutical Industry Experience We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Oct 19, 2019
Full time
Your Responsibilities The Facilities Maintenance Manager is responsible for managing the design, planning, construction and maintenance of the organization's building, machinery and related items. Ensures organizations goals are met by having facilities and/or manufacturing machinery in excellent condition. Your Tasks Troubleshoot, evaluate and make recommendations to upgrade maintenance operations and/or implement saving opportunities Plan projects for facility improvements from concept to completion Perform routine and non-routine equipment maintenance, modification and repairs in a timely basis Create and implement an effective preventative maintenance program Forecast budget for the facilities department and monitor throughout the year Document repairs, adjustments and replacement of equipment per SOP's and cGMP regulations Write and update SOP's, as needed Negotiate, maintain, and review contract for all third party contractors, cleaners, waste removal, vending, recycling, security provider, etc. Complete and coordinate with department heads all repairs, as necessary, to offset downtime and production delays Ensure that all work performed by vendors is billed correctly and within budget Respond immediately to all emergency situations Assist maintenance contractors if applicable in trouble shooting of equipment Order parts and components for repairs as needed Assist with the organization and inventory of spare parts Maintain a clean and well organized maintenance room Provide after hours on call support including holidays Must follow all safety rules and ensure compliance Your Profile Bachelor's Degree with 5 years' work experience, or Minimum of 8 years relevant work experience At least 8 years' experience in facilities maintenance: including but not limited too electrical, plumbing, HVAC, carpentry, refrigeration, and/or equipment Knowledge of cGMP manufacturing and basic chemical safety procedures Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Familiarity of standard laboratory practices Familiar with Environmental Health and Safety regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity Nearest Major Market: San Diego
Bachem Vista, CA, USA
Oct 15, 2019
Full time
Your Responsibilities The Senior Process Engineer/Project Lead is responsible for plans, design, development, implementation, and analysis of technical products, manufacturing processes and systems in an industrial plant with consideration of safety. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, process and/or procedures. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines parts and tools needed in order to achieve manufacturing goals according to product specification. Lead project team and drive project milestones to design, develop, project, and improve processes materials flow. Your Tasks Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system Lead technical activities associated with the development and qualifications of new production line and equipment Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology. Develop and train cross-functional team members on utilization and maintaining new equipment and system - by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations Lead and support site development and production capacity expansion efforts Develop process and provide guidance for to improve engineering and project programs Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures Your Profile Bachelor's Degree in Engineering Minimum of 7 years' relative work experience Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities Working Knowledge of cGMP, GDP, GEP engineering principles Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21 Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development Experience in handling hazardous materials and chemicals Excellent written and oral communication skills Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Detail oriented with the ability to troubleshoot and resolve problems. Ability to work independently, manage one's time, and function well in a team environment Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Sep 30, 2019
Full time
Your Responsibilities The Project Chemist will work independently to achieve goal-oriented solutions in development for optimizing and troubleshooting of production processes in Liquid Phase and/or Solid Phase-synthesis. This position will work in conjunction with the management of the production groups; and will coordinate with other departments Your Tasks Work Independently to develop, optimize and troubleshoot projects Collaborate with the planning department to plan the necessary resources in order to guarantee a smooth and efficient execution of projects with optimized utilization of all resources Organization of procedures and coordination internally with other departments (R&D, QC, Services, etc.) Create and update SOPs as needed Prepare Development reports of outcomes Present outcome/results of projects with stakeholders Continual supervision/monitoring of working techniques, technologies and processes Support for the (preventive) maintenance and responsibility for department owned equipment and infrastructure Support in planning and implementation of investment projects to achieve higher capacity, compliance or new technologies Timely information of the particular stakeholders about status and results of work and tasks in progress Coordination of analytical work orders and control of the received analytical results Coordination of investment and maintenance projects with the particular department Professional application and assurance of different directives, regulations and instructions Realize improvement opportunities for safety compliance Follow good housekeeping in the work environment Professional disposal of chemical waste Responsibility for production equipment/assets Your Profile PhD Master's Degree in Chemistry or a Science related field Good knowledge of peptide/oligonucleotide chemistry Minimum of 7 years in Organic Synthesis Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve technical and analytical problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Experience with Master Control and SAP Industry experience Understanding of GMP according to ICH Q7 We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Sep 30, 2019
Full time
Your Responsibilities The Project Chemist will work independently to achieve goal-oriented solutions in development for optimizing and troubleshooting of production processes in Liquid Phase and/or Solid Phase-synthesis. This position will work in conjunction with the management of the production groups; and will coordinate with other departments Your Tasks • Work Independently to develop, optimize and troubleshoot projects • Collaborate with the planning department to plan the necessary resources in order to guarantee a smooth and efficient execution of projects with optimized utilization of all resources • Organization of procedures and coordination internally with other departments (R&D, QC, Services, etc.) • Create and update SOPs as needed • Prepare Development reports of outcomes • Present outcome/results of projects with stakeholders • Continual supervision/monitoring of working techniques, technologies and processes • Support for the (preventive) maintenance and responsibility for department owned equipment and infrastructure • Support in planning and implementation of investment projects to achieve higher capacity, compliance or new technologies • Timely information of the particular stakeholders about status and results of work and tasks in progress • Coordination of analytical work orders and control of the received analytical results • Coordination of investment and maintenance projects with the particular department • Professional application and assurance of different directives, regulations and instructions • Realize improvement opportunities for safety compliance • Follow good housekeeping in the work environment • Professional disposal of chemical waste • Responsibility for production equipment/assets Your Profile • PhD • Master's Degree in Chemistry or a Science related field • Good knowledge of peptide/oligonucleotide chemistry • Minimum of 7 years in Organic Synthesis • Excellent written and oral communication skills • Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues • Detail oriented with the ability to troubleshoot and resolve technical and analytical problems • Ability to work independently and manage one's time • Communicate effectively and ability to function well in a team environment Preferred: • Experience with Master Control and SAP • Industry experience • Understanding of GMP according to ICH Q7 We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Sep 30, 2019
Full time
Your Responsibilities The Quality Engineering (QE) Director is responsible for overseeing Quality Engineering teams who support validation and qualification of equipment, facilities/utilities and cleaning validation activities for API manufacturing at both Bachem America's locations (Vista & Torrance). The incumbent will provide leadership and guidance to the QE managers and QE employees. The QE Director will lead the harmonization of validation processes at both Bachem sites. This position is responsible for managing, developing and implementing validation processes to ensure products meet the appropriate regulatory agency's validation requirements, internal company standards and current industry practices. This position will work in close cooperation with Manufacturing, Engineering and other functional areas in managing validation activities under the QE scope of work. Responsible for presenting validation practices during the regulatory agencies and customers audits. Your Tasks Hire, manage, and develop teams to support validation activities at both locations Manage continued growth, development, and retention of the team Set strategic direction for the QE organization Responsible for making key decisions and formulating policies that are aligned with strategic objectives of the QE function and Bachem Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases Develops key performance metrics that measure the effectiveness of the QE organization Develop validation master plan (VMP) to assure compliance with regulatory requirements Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures Conduct and document investigations related to validation activities Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements Your Profile Bachelor's Degree in science related field (engineering, chemistry, or equivalent) Minimum of 10 years pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures At least 5 years of experience in people management and leadership Experience in drug GMP manufacturing Strong knowledge of GMPs, FDA & EU guidelines/requirements related to validation Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement Experience in writing standard operating procedures and technical reports Excellent written and oral communication skills Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Master's Degree in science related field Six Sigma Green or Black Belt We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Sep 30, 2019
Full time
Your Responsibilities The Lyophilizer Maintenance Engineer will be responsible for maintenance, troubleshooting, and corrective actions for all lyophilizer equipment in current operation at the site. This individual will be responsible for all projects and services related to the lyophilizers including the timely completion of repairs while adhering to standard operating practices. In addition, he/she will be responsible for routine visual and physical inspections. Your Tasks Responsible for maintenance and operational procedure for over six freeze dryers Responsible for maintenance and operational procedure for lyophilizer equipment Participate in engineering designs, specifications selections, change of parts and implement necessary changes through engineering change control procedures Participate in lyophilization process and cycle designs; implement the necessary process change through engineering change control procedures Collaborate with the validation department regarding change control requalification and validation of change Participate in customer and end-user meetings related to lyophilization as the subject matter expert Participate in writing, review and implementation of corrective actions related to lyophilizer mechanical or process deviation Use understanding and knowledge of PLC control engineering to participate in making necessary changes in process and mechanical control Collaborate with Quality Assurance in PR and SOP writing, and participate in review and corrective action related to mechanical or process deviation of equipment Complete paperwork required for equipment and maintenance data into the department's and calibration processes Your Profile Bachelor's Degree in Electrical, Mechanical or Industrial Engineering with at least 6 years related experience or AA Degree with 10 years related experience or High school degree with 15 years experience Direct related experience with electronica controls and refrigeration system knowledge, including low temperature cascading systems and two stages compressor. Specific knowledge of vacuum systems, hydraulic system and electrical circuit and control Electronic controls and refrigeration systems knowledge, including low temperature cascading systems and two stages compressor Understanding / knowledge of PLC control, preferably Allen Bradley and OM RON. Strong analytical math and problem solving skills Proficient in reading schematics and diagrams as well as other written materials High level of safety awareness Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve equipment problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with -50◦ Celsius refrigeration We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Sep 29, 2019
Full time
Boston, MA Area Your Responsibilities The Business Development Manager will be responsible for actively selling NCE and Generic products and services to prospective customers, and manage business relationships to deliver year on year revenue and pipeline targets. Must maintain a thorough understanding of the customer's business and act as an advocate internally to cultivate and maintain positive customer relationships. The BD manager will need to leverage internal team expertise (Project Management, Regulatory, R&D, etc.) to resolve problems and add value to company's offerings. Your Tasks Pursue new business opportunities consistent with company's capabilities, and develop value propositions and action plans to increase the project portfolio/pipeline Maintain and utilize specified account KPI measures (including accounts receivable) and business systems to confidently forecast revenue and demonstrate a high level of account management and control Leverage the standard sales process and tools, business systems, and appropriate business support functions to support new customer and new project acquisitions Distill customer requirements and qualify project leads before presenting to operational functions Leverage internal team expertise to resolve problems and follow through on commitments, elevating critical issues to the appropriate management level for removal of organizational barriers to resolve customer problems Monitor competitive activity and trends within the industry and continually adapt presentation and product offerings for contemporary image. Plan and perform the selling, proposal, and contract negotiation processes Plan and perform the development and deployment of robust value propositions and action plans to close deals effectively and maximize margin Maintain CRM for customer accounts Collate and feedback relevant market and account intelligence from the field to support on-going development of Bachem's competitive intelligence and market positioning Remain engaged in ongoing projects to help ensure that deliverables, time lines, quality standards, and (most important to this role) customer expectations are met Gather and communicate relevant market information to sales and marketing management Ensure that quotes and meeting updates are submitted in a timely manner Attend trade shows, seminars, and other industry events, while actively engaging with those participants in order to represent company business interests and increase brand awareness Support sales management by performing sales-related research and reporting as assigned Your Profile BS degree in science-related field 3-5 years of experience in business development within a CMO/CDMO, or other direct exposure to API manufacturing, sourcing, or development Demonstrated negotiation and presentation skills The ability to serve as a business partner, and build relationships based on trust, engagement, and long term commitment The ability to travel up to 40% (50% to meet goals) for customer meetings, conferences, and seminars Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: MS or PhD a plus Project management skills/experience Knowledge of peptide synthesis Knowledge of pharm/biotech markets and related global trends Ability to pursue and close deals, and maintain motivation when faced with challenging situations Experience with Salesforce or other CRM tool We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Sep 29, 2019
Full time
Your Responsibilities The Business Development & Support Manager is responsible for all the administration tasks of the Business Development team with particular emphasis on further development of business processes, especially in connection with the IT systems used (SalesForce and SAP). The Team Leader assumes overall responsibility for the provision, optimization and expansion of the CRM system as well as for the smooth execution of the order processing of all customer orders from Bachem Americas whilst ensuring their team is capable of continuous support of the Business Development team. Your Tasks The smooth flow of order development for all customer orders from Bachem Americas The coordination of shipping to customers with / from all locations The training of new employees in the ERP and CRM system The up-to-date keeping of training documents and guidelines in the ERP environment The execution of existing reports and for the creation of new reports The support of the BD & Sales management in administrative tasks As CRM application owner, lead global projects for continuous development of the system Assist the CRM application by implementing approved changes Developing and establishing Salesforce administrators for the CRM application A smooth onboarding of new employees in the CRM application process The creation of new reports / dashboards from the CRM application The constant revision of manuals within and for the CRM application Assist with the ERP process owner by managing the constant questioning, improvement, documentation and implementation of business processes. Implementing processes in conjunction with other ERP teams The development and establishment of an "ERP and process competence center" within the BD/PM teams The support of the key users of the ERP system as well as the key-users business data within his team The development of new employees and substitutes for the key-user role if necessary A regular review and improvement of the process strategy, Voting and adaptation with the involvement of global stakeholders Your Profile Bachelor Degree with minimum 5 years work experience in a relevant field . Work experience and understanding of the pharmaceutical/biotech industry preferred In depth knowledge of SalesForce and SAP Strong knowledge and command of the English language. Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Experience of SAP and SalesForce integration implementation We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Vista, CA, USA
Sep 29, 2019
Full time
Your Responsibilities The Director of Production oversees all production operations within their department to ensure they meet the required deadlines, quality standards, and ensures that projects are completed within the operational budget. The Director of Production oversees all personnel assigned to them. They select, hire and train new employees and contribute in appointing managers and supervisors. They evaluate employees routinely and ensure standards of performance are met within the production group. They assign responsibilities to supervisors and employees on the production line for each project. The Director of Production implements quality-control programs and policies. They routinely analyze production budgets and make changes as necessary. Throughout the production process, the Director oversees the workers and the process to ensure safety procedures are followed and performance goals are met. The Director of Production also creates production reports for review by top executives. Your Tasks Supervise and manage a team of Production Managers, Chemists and Technicians Direct and work with production team of managers, chemists and technicians to manage production workflow, schedule and quality Monitor production activities and adjust schedule to ensure on-time delivery Develop process improvements to optimize production speed and quality Establish and enforce production and quality standards Motivate team members to deliver exceptional work and exceed expectations Organize job trainings for team members to achieve business objectives Maintain all production related documentations for future reference purposes Ensure that final product meets quality standards and customer specifications Understand customer requirements and prepare production plan accordingly Create, update and implement policies and procedures for manufacturing Evaluate new equipment and technologies Enforce cGMP guidelines Maintain a clean and safe work environment by educating and directing personnel on the use of control points, equipment and resources Maintain compliance with established safety policies and written procedures Develop growth opportunities for employees Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, benchmarking state of the art industry practices, and participating in professional societies Ensure that reporting employees receive adequate environmental, health and safety training Ensure that any operating or occupational accidents and incidents involving employees reporting to you are properly recorded and investigated to a productive conclusion. This includes ensuring employees are appropriately monitored and managed to address unacceptable levels of performance Ensure a positive safety culture is developed within the area, and is supported by robust safety processes in accordance with industry standards and legislation Ensure safety arrangements are adhered to and protect the health and safety of employees, visitors, contractor, and the public Orientation Training Your Profile Ph.D. Degree in Organic Chemistry or related field with 10 years related experience or Masters in Organic Chemistry with 15 years related experience Managerial experience in cGMP manufacturing Strong knowledge of organic chemistry Proficient with large scale manufacturing Proficient with various in-process analytical methods Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve technical and analytical problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Peptide manufacturing experience We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Bachem Torrance, CA, USA
Sep 28, 2019
Full time
Your Responsibilities The Materials Management Supervisor is the subject matter expert, SAP Key User, in relation to SAP and business practices within the Materials Management Department. As the subject matter expert, the Materials Management Supervisor is responsible for the daily scheduling and operational oversight of the receipt of material; inventory control; raw material receiving, sampling; dispensing; issuing material to production; finished peptide sampling; dispensing; packaging; and labeling. They must be able to work in a fast-paced environment, prioritize competing demands, supervise the team through task completion, and communicate effectively. The Supervisor ensures accurate, timely, and complete documentation and SAP transactions are being completed in a timely manner. This individual will also lead MM SAP troubleshooting and testing support as needed. Ensures that all Materials Management functions are carried out in compliance with Current Good Manufacturing Practices (cGMP), Occupational Health and Safety Administration (OSHA), and the Sarbanes Oxley Act (SOX) as well as all Bachem Standard Operating Procedures (SOPs). Your Tasks Provide leadership, training, and daily operational guidance to Materials Management personnel in the areas of receiving, inventory control, sampling, material transfers, finished goods sampling, dispensing, packaging and distribution. This is all to be done through the execution of cGMP procedures Write performance reviews and manage a small team within the Materials Management group Oversee work of direct reports: distribute workload, and cross-train staff Maintains clean, organized, compliant and safe storage, dispensing, and office areas Provides recommendations to Materials Management leadership regarding process improvements Responsible for the correct receipt of all incoming materials Confirms all material received is properly received and transferred to the intended recipient Confirms all material received through a purchase order is properly received and transferred to the correct storage location Confirms material received matches the PO and processes receipt transactions Confirms documentation, and performs receiving inspections, for receipt of all materials Coordinates material movement, sampling, release and labeling of raw materials and components with Quality Assurance Resolves transfer issues for all received raw material Interacts with suppliers, Purchasing and Accounting personnel to resolve receipt and/or invoice discrepancies; coordinates and completes Return to Vendor transactions Operates material handling equipment in the movement and storage of materials Coordinates material and product transfer requirements directly with Production and Quality Assurance Must be capable of performing the physical tasks involved in receiving, storing, transporting, dispensing and issuing of raw materials and finished products Performs timely inventory transactions in the Enterprise Resource Planning (ERP) system SAP Responsible for supporting complete and accurate inventory transaction documentation and record keeping Maintains required segregation, security, labeling and storage conditions for all warehouse materials Performs directed cycle counts, evaluates variance reports, investigates discrepancies and recommends corrective actions Reviews inventory for potential expired, scrap or obsolete material. Maintains First-Expiry, First-Out (FEFO) practices Monitors and reports storeroom inventory levels for manufacturing consumable supplies Monitors and reports inventory levels of all bulk solvent materials Act as a liaison between business and IT organizations Provides support to other Departments as required for non-GMP materials Lead the daily support to MM on any SAP related issues, including troubleshooting and training Maintains strict level of GMP compliance in all areas of responsibility Schedules and ensures timely execution of raw material dispensing operations to support production Schedules and ensures timely execution of finished goods dispensing and packaging operations. Ensures proper labeling, handling, and storage of dispensed materials and transfer dispensing material utilizing the ERP system Ensures all raw material and finished goods dispensing documentation and ERP entries are complete and accurate Ensure that all quality events assigned are closed out in a timely manner Your Profile Associate Degree or a Minimum of 5 years' experience in supply chain leadership preferably in a pharmaceutical / biotech manufacturing cGMP environment At least 7 years of combined experience within multi-site distribution, logistics, and warehouse operations in a cGMP pharmaceutical/biotech manufacturing environment Experience as an SAP Key User Familiar with aseptic processes, e.g. gowning and working in a clean room environment Solid understanding of business processes and SAP Knowledge of handling temperature sensitive products including working in cold storage areas Ability to lead, motivate and small teams Ability to manage multiple responsibilities with a high degree of self-motivation Ability to work independently, as well as manage others, in a fast-paced, dynamic environment Ability to clearly communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Strong analytical and problem solving skills Detail oriented and highly accurate with numerical information. Must be computer literate, (Microsoft Word, Excel and PowerPoint) and have in-depth knowledge of inventory control systems Experience operating material handling equipment Experience working with chemicals and hazardous material Use of personal protective equipment, (PPE) including respirators and gowning Preferred: Experience in the peptide industry Familiarity with DOT, IATAA regulations APICs and/or ISM certification desired. We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles
Bachem Torrance, CA, USA
Sep 25, 2019
Full time
Your Responsibilities The Senior Process Engineer/Project Lead is responsible for plans, design, development, implementation, and analysis of technical products, manufacturing processes and systems in an industrial plant with consideration of safety. Performs engineering design evaluations. Recommends alterations to development and design to improve quality of products, process and/or procedures. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Determines parts and tools needed in order to achieve manufacturing goals according to product specification. Lead project team and drive project milestones to design, develop, project, and improve processes materials flow. Your Tasks Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system Lead technical activities associated with the development and qualifications of new production line and equipment Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology. Develop and train cross-functional team members on utilization and maintaining new equipment and system - by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations Lead and support site development and production capacity expansion efforts Develop process and provide guidance for to improve engineering and project programs Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures Your Profile Bachelor's Degree in Engineering Minimum of 7 years' relative work experience Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities Working Knowledge of cGMP, GDP, GEP engineering principles Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21 Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development Experience in handling hazardous materials and chemicals Excellent written and oral communication skills Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Detail oriented with the ability to troubleshoot and resolve problems. Ability to work independently, manage one's time, and function well in a team environment Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles