Cell & Gene Therapy Cmc Compliance Head (M/F) /d

vor 3 Wochen

Basel, Schweiz Bayer Vollzeit

**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 & Gene Therapy CMC Compliance Head M/F/d**

**YOUR TASKS AND RESPONSIBILITIES**
- Support quality oversight of CGT products along all platforms and domains,
- Support projects compliance oversight with EMA, FDA and other relevant regulations,
- Provide CMC and QA expertise for CGT companies particularly to ensure adequate preparation of INDs / IMPDs/ BLAs for different markets.

**Key Tasks**:

- Provide CMC and QA expertise for CGT companies particularly to ensure adequate preparation of INDs / BLAs.
- Key QA expert and contact for Regulators Affairs (RA) for CGT companies.
- Provide QA Support of Regulatory Affairs activities for CGT and central connection to RA units in CGT companies / platforms, Bayer manufacturing, Bayer Biologics Development and Chemical & Pharmaceutical Development groups during tech transfers (when applicable).
- Support end-to-end Quality Compliance oversight on CGT products for all platforms and domains for all clinical stage assets and link to RA units for commercial phase
- Ensure QA compliance of the regulatory documentation with EMA, FDA and other relevant regulations
- Provide inputs into the regulatory strategy (scientific advice meetings, type II meeting) and establish minimum control strategy across CGT (i.e. minimum set of common regulatory approaches).
- Facilitate cross functional and cross platform Regulatory support for all CGT products to bring the innovative products fast and efficiently to submission.
- Establish a strategy to support fast and efficient development and seamless transition to commercialization in collaboration with RA functions which become responsible for commercial phase.
- Support establishment of CGT QMS & Compliance at CGT companies.
- Partner with Bayer functions
- Facilitate knowledge exchange across CGT satellites and Bayer functions and promote best practices (to ensure ramp up of capacity and knowledge within Bayer).
- Regulatory CMC interface for CGT products

**WHO YOU ARE**
- PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field Strong understanding of contemporary molecular biology methods with hands on experience.
- Long term Pharma Industry Experience
- A demonstrable grasp of a wide range of analytical technologies (qPCR, ddPCR, ELISA, SDS-PAGE, in-vivo potency) as applied to gene therapy products is preferred.
- Working in a cGMP environment and experience in writing regulatory documents (BLA/IMPDs/INDs for CGT products) is required.
- Deep understanding of the Quality Requirements for early phases & late phases for genes therapies and or cells therapies products, is required.
- Exposure and Quality understanding to a variety of modalities (gene therapy, cell therapies, others) is required.
- Experience in GMP/ GCP Inspections for CGT products, involving complex regulatory requirements is required (conducting, supporting, and or hosting).
- Experience implementing systems, processes and best practices for support of cross-functional activities Ability to troubleshoot critical issues or problems and resolves routine issues using appropriate information.
- Driven by creating value for the customer (patient).
- Fluent and able to negotiate at C-level in English

LI-GH

**YOUR APPLICATION**

**Location**:
Switzerland : Basel-City : Basel

**Division**:
Pharmaceuticals

**Reference Code**:
783938

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