Director, Strategist QC & Analytics Cell Therapy

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

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;