Bayer-posted 4 months ago
$170,438 - $255,657/Yr
Full-time • Director
Berkeley, CA
5,001-10,000 employees

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. 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. The 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.

  • 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.
  • 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.
  • 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).
  • Healthcare
  • Vision
  • Dental
  • Retirement
  • PTO
  • Sick leave
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