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CTMOD Quality Ops Functional Lead
CTMOD Quality Operations Functional Lead – Berkeley, CA
PURPOSE
The CTMOD Quality Operations Functional Lead provides QA expertise & oversight for CT Activities (Com, Clinical, Dev, current focus on DA01) @ CTMOD (B69) and @ CTlab when required. Quality representative in the assigned DA01WorkStream and related missions teams.
Supports the implementation and maintenance of the quality assurance processes and procedures for CTMOD & CTLAB Facilities, through close collaborations with Biologics Q Capability Pool personnel.
Provides functional leadership for managing the scheduling, resource planning and execution work required to implement and maintain these QA processes and procedures. Utilizes and provides expert knowledge in developing, implementing and maintaining quality assurance processes, standards and procedures.
Supports and manages the planning and coordination of QA activities related to new and modified existing facilities, systems and equipment.
YOUR TASKS AND RESPONSIBILITIES
Operational:
Member of CGT Quality Assurance Team;Participate in Biologics QULT PSS and Staff Meetings;Supports CTMOD & CTLab teams for CT manufacturing activities (routine and launch activities and works with site to execute project milestones and deliverables in a compliance manner, Accountable for shopfloor QA oversight, prioritization, and coordination of tasks, Primary contact with CTMOD &CTLab Operations team;Responsible for back up activities for CGT QA SMEs. Accountable for ensuring CGT Q Head is informed of operational QA activities, progress to milestones, and escalations;DA01 Strategy:
For the DA01 Works Streams and related mission’s teams, develops and owns product quality strategy and co-creates the control strategy (incl. critical quality attributes, release criteria, in process controls, stability) together with the different partners;Operational / CAPEX Project related responsibilities:
Executes / Support Quality tasks for CTMOD, including but not limited to:Quality systems and processes establishment needed to enable compliant operations, maintenance, and works with site teams to integrate with and influence revisions, where applicable, of existing site systems;Inputs, reviews and approves process descriptions, process control strategies and recipes (automation);Inputs, reviews and approves qualification strategy & documentation and supports execution;Inputs, reviews & approves project/equipment/ facility related documents;Reviews and approves Production documents for operation of equipment and area, such as SOPs, BPRs, Sample tables etc.;In collaboration with QA Batch release team, support/conduct QA Batch Record Review, in collaboration with QADCM team lead/ support trouble shooting activities related CT products (i.e Support/ Lead root cause investigation and or approve Deviation Report);Provides support for inspections / audits and support the review corrective actions.WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
REQUIRED QUALIFICATIONS
Bachelor of Science in Engineering, Biology, Chemistry, Biochemistry or related field;10 or more years of Pharmaceutical and/or Biotechnology, with Cell Therapy Technology experience;Understanding of IPSCs manufacturing;5-10 years of experience working in a cGMP environment in the pharmaceutical or biotech industry (with Aseptic Operations including shopfloor activities) or an equivalent combination of education and experience;Experience in cGMP for cell therapy products, particularly with IPSCs;Experience in Aseptic Operations, with significant QA Oversight experience;Advanced working knowledge of Good Manufacturing Practice (cGMP) including ISO Standards for the development, manufacture and commercialization of biologics and Cell Therapy (preferred) products;Ability to influence, to work independently and to self-motivate;Ability to multitask and support changing priorities;Ability to solve complex problems requiring in-depth technical, scientific and engineering knowledge, in a compliant manner and under pressure of timelines.
PREFERED QUALIFICATIONS
15 years of Pharmaceutical and/or Biotechnology, with Cell Therapy Technology experience.
Employees can expect to be paid a salary between $171,480.00 to $257,220.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..
This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
This posting will be available for application until at least 8-4-2025.
YOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.