Cell and Gene Therapy CMC Compliance Head
Vor 5 Tagen
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.
Cell and Gene Therapy CMC Compliance Head (m/f/d)
Support quality oversight of Cell and Gene Therapy (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 Regulatory CMC interface for CGT products.
WHO YOU ARE:
- PhD/MD in Biotechnology, Virology, Cell Engineering, Pharmaceutical Technology, or related field;
- 15 years of experience in the pharmaceutical industry;
- Strong understanding and hands-on experience with molecular biology methods;
- Required experience in a cGMP environment and writing regulatory documents for CGT products;
- 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. Fluency in German will be a plus.
This role will be open for applications until at least 2nd April.
Location: Switzerland : Basel-City : Basel
Division: Pharmaceuticals
Reference Code: 840959
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