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Cell Therapy Manufacturing Science Expert
The primary purpose of the Cell Therapy Manufacturing Science Expert is to focus on end-to-end process and manufacturing readiness and implementation of cell therapy products and technologies from development to manufacturing within the Berkeley CT GMP environment. This position acts as a crucial link between CMC and manufacturing capabilities. This role requires a deep understanding of cell therapy processes and GMP requirements, strong project management skills, and the ability to collaborate effectively with various stakeholders to meet and drive project milestones and deliverables.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Cell Therapy Manufacturing Science Expert, are to:
Lead Technology Transfer Projects: Oversee the development, transfer, and commercialization of cell therapies to the CT MOD facility, establishing an integrated technology transfer and technical support system and process.Act as Connector: Serve as a pivotal liaison between CMC&T and Manufacturing Biologics to ensure seamless technology transfer, implementation and lifecycle management (LCM) support of cell therapies into CT-MOD.Cross-Functional Collaboration: Collaborate with CMC&T, Quality Assurance, and Manufacturing teams to align on project goals and deliverables related to cell therapy processes as part of process and GMP/NPI readiness workstreams.Documentation Management: Develop and maintain comprehensive project documentation, including (but not limited to): process descriptions, risk assessments, reports, SOPs, plans, protocols, and reports to support technology transfer and lifecycle management support activities for cell therapies. Ensure MFG process documents (EBRs, DEV, CCR, etc.) properly reflect process requirements, definitions and sufficiently emphasize key and critical steps, parameters and attributes.Risk Management: Identify potential risks associated with cell therapy processes and implement mitigation strategies, including owning and conducting risk assessments for process, raw materials or other aspects of the process.Training and Support: Conduct training sessions for manufacturing personnel on new cell therapy processes and technologies, ensuring training reflects process requirements and compliance.Lifecycle Management and Process Performance Monitoring: Provide on floor technical support. Lead and build sustainable technical support team and process. Monitor and analyze process performance post-transfer and throughout regular production, making recommendations for continuous improvement in cell therapy production.Technical Expertise: Provide technical expertise for engineering, conformance/validation and GMP runs, troubleshooting, and investigations, serving as a subject matter expert on cell therapy technology transfer processes and best practices. Lead investigations and build teams for sustainable on floor support as needed. Partner with subject matter experts for analytical methods to support parallel method transfer of analytical methods in an integrated strategy with process transfer.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Degree in chemical engineering, bioprocessing science, biological sciences or similar field with biotechnology industry experience in a biotechnology or pharmaceutical company, or similar industry environment. Strong experience in the cell therapy modalities (pluripotent stem cells, allogenic cell therapy and/or iPSCs), manufacturing process development, tech transfer, and cGMP manufacturing.Significant hands-on experience in developing, optimizing, implementing, and qualifying cell culture processes according to industry best practicesIn-depth knowledge of biologics processes, technology development, and comprehensive understanding of GMP requirements in CMC development and manufacturing, with preferred focused with cell therapies.Strong stakeholder management and engagement skills, with a proven ability to build and maintain relationships across various organizational levels.Proficiency in data analysis and problem-solving techniques.Strong analytical and problem-solving skills, with a track record of implementing innovative solutions in product development.Excellent verbal and written communication skills, with proficiency in negotiation and conflict resolution at all levels, with internal and external stakeholders (i.e. health authorities).Credibly embodies and role models Visionary, Architect, Catalyst, and Coach (VACC) leadership behaviors:Demonstrate high self-awareness as well as system awareness.Demonstrate strategic thinking as well as good business and external trends insights.Focus on outcomes: defines and deliver highest pipeline, team, talent and organizational impact outcomesCollaborate with accountability: collaborates and holds each other accountable in and across teamsCo-create for customers: is close to the customer and co-creates solutions for their needsAct, learn fast and evolve: works in 90-days cycles, applies learnings fast and continually developsIs the best self and includes others: respects differences, embraces inclusion and shows up as the best self.
Preferred Qualifications:
• Degree in chemical engineering, bioprocessing science, biological sciences or similar field with 15+ years of experience with PHD, or 17+ years of experience with Masters, or 19 + years of experience with a Bachelors.
Employees can expect to be paid a salary of between $149,000 – $223,000. Additional compensation may include a bonus or commission (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 8/24/2025
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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.