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.

CGT CMC Compliance Head 

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.

The Cell and Gene Therapy CMC Compliance Head will support quality oversight of CGT products across all platforms and domains; ensure compliance with EMA, FDA, and other relevant regulations; provide CMC and QA expertise to CGT companies to prepare INDs, IMPDs, and BLAs for various markets. As a global role, you will be instrumental in maintaining high standards and facilitating seamless transitions from development to commercialization.

YOUR TASKS AND RESPONSIBILITIES:

• Provide CMC and QA expertise for CGT companies, ensuring preparation of INDs and BLAs;
• Act as the key QA expert and contact for Regulatory Affairs in CGT companies;
• Support Quality Compliance oversight for CGT products throughout clinical and commercial phases;
• Ensure QA compliance of regulatory documentation with EMA, FDA, and other regulations;
• Contribute to regulatory strategy and establish control strategies across CGT;
• Facilitate cross-functional regulatory support to expedite product submissions;
• Develop strategies for efficient development and commercialization in collaboration with RA functions;
• Support the establishment of CGT QMS & Compliance;
• Promote knowledge exchange and best practices across CGT satellites and Bayer functions;
• Serve as the Reg CMC interface for CGT products.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• PhD/MD in Biotechnology, Virology, Cell Engineering, Pharmaceutical Technology, or related field;
• Strong understanding and hands-on experience with molecular biology methods;
• Deep understanding of quality requirements for gene and cell therapy products;
• Exposure to diverse modalities in gene and cell therapies;
• Experience in GMP/GCP inspections for CGT products;
• Ability to implement systems and troubleshoot critical issues;
• Driven by creating value for the customer (patient);
• Fluent in English, with negotiation skills at the C level.

Preferred Qualifications:

• A demonstrable grasp of a wide range of analytical technologies (qPCR, ddPCR, ELISA, SDS-PAGE, in-vivo potency) as applied to gene therapy products;
• 15 years of experience in the pharmaceutical industry;
• Fluency in German.

Employees can expect to be paid a salary between $150,381.60 to $225,572.40.  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 May 6th 2025.