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Director, Strategist QC & Analytics Cell Therapy
The Director, Strategist QC & Analytics for Cell Therapy at Bayer is instrumental in providing strategic, scientific, and regulatory guidance for our late-stage cell therapy pipeline with a primary focus on supporting Bemdaneprocel, an innovative first-in-class therapeutic for Parkinson’s disease. This role demands scientific excellence and the ability to interpret complex, large data sets, alongside a comprehensive understanding of regulatory frameworks and GMP compliance. The successful candidate will translate product and process knowledge into science-driven quality decisions. Key responsibilities include curating a product data lake, developing tailored analytical control strategies, and transforming scientific insights into a commercially viable product quality profile.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of the Director, Strategist QC & Analytics for Cell Therapy are to:
Develop and refine the analytical product quality strategy, including critical quality attributes, release criteria, in-process controls, and product stability, in collaboration with the process owner and analytical product lead;Curate and analyze data from the analytical product data lake to formulate a science-driven, process- and product-specific quality strategy;Review and contribute to regulatory submissions, including INDs and BLAs;Co-create regulatory roadmaps to ensure readiness for BLAs and suitability for commercial manufacturing;Oversee product-specific long-term analytical lifecycle management;Serve as a leader or active member of interdisciplinary project teams or task forces;Establish yourself as a key scientific resource within Bayer’s Cell Therapy workforce;Provide expertise in analytics and quality control, offering consultancy for troubleshooting activities and participating in expert communities;Support the development of local knowledge and facilitate ongoing training and qualification for the Cell Therapy workforce at Bayer.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following qualifications:
Required Qualifications:
Bachelor’s degree in cell biology, neurobiology, biotechnology, molecular biology, biochemistry, or related field;Strong scientific foundation in cell biology, with a preference for expertise in stem-cell-and/or neurobiology;Knowledgeable in analytical techniques and methodologies related to cell therapy (e.g., flow cytometry, Imaging technologies, potency assays, molecular biology, next generation sequencing and other characterization techniques);Expertise in the development and qualification/validation of a wide range of cell based and biochemical assays for release, stability and extended characterization testing of biological entities;Strong background in data analysis, mining and interpretation of large datasets;Proven experience as a QC project lead or manager for clinical stage program (ideally late phase) or in lifecycle management activities for a commercial biotech product, most desirable with a focus on cell therapy;Comprehensive knowledge and understanding of CMC-related regulatory frameworks pertaining to clinical development and license applications for New Biological Entities (NBEs), particularly in the context of cell therapy;Extensive experience working in a GMP environment, with a solid understanding of relevant regulations;Demonstrated expertise in Quality Risk Management, including the ability to conduct comprehensive risk assessments and develop effective mitigation strategies to ensure analytical product quality;Exceptional team player with strong negotiation skills;Demonstrated ability to solve complex problems and effectively structure and simplify strategic tasks;Capacity to critically challenge the status quo and underlying assumptions to foster innovation, with a track record of driving ideas to successful outcomes.
Preferred Qualifications:
Ph.D. in cell biology, neurobiology, biotechnology, molecular biology, biochemistry, or related field +7 years of relevant experience in the cell therapy and/or biopharmaceutical industry (or MS + 10 years, or BS + 12 years).
Employees can expect to be paid a salary between $170,438.40 - $255,657.60. Additional compensation may include a bonus or commission (if relevant). Additional benefits include healthcare, 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, skills, prior relevant experience, certain degrees and certifications, and other relevant factors.This posting will be available for application until at least 9/8/2025.
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.