Competitive
- Berlin, Germany
- Permanent

An exhilarating opportunity awaits at a dynamic clinical-stage biotech company that seeks a Senior Director Late-Stage CMC Development for their Berlin site. This international company boasts a robust pipeline in various therapeutic areas and owing to their triumphs in clinical trials, is expanding across diverse teams. They are actively seeking skilled professionals in the field of gene therapy.

**Role Purpose**
- Developing and implementing strategies for **Late-Stage** **CMC Development**:

- Executing manufacturing plans
- Managing Contract Manufacturing/Testing Organizations for Drug Substance and Drug Product
- Coordinating analytical life cycle activities
- Executing Regulatory strategies
- Manage and support CMC Project Leaders for late-stage programs.
- Ensure GMP compliance within the manufacturing network in collaboration with GMP QA.
- Coordinate drug substance and product manufacturing, process development, scale-up, and clinical manufacturing.
- Ensure analytical lifecycle requirements are met at CMOs in partnership
- Communicate accurate forecast requirements for starting materials to internal teams.
- Provide technical input for resolving Product Quality Investigations.
- Generate and archive scientific reports, regulatory documents, IP, and status reports.
- Review and contribute to CMC regulatory documentation for IMPDs, INDs, etc.
- Manage people and functional budgets.
- Allocate resources for plans, protocols, records, SOPs, risk assessments, and contracts.

**Qualifications**:

- **Advanced degree** in Chemistry, Pharmacy, or related natural science (PhD preferred).
- **12-15 years of pharmaceutical/biotech industry experience**, including **5 years in management**.
- Strong expertise in **GMP Manufacturing** (DS and DP), **GMP QA**, Biologics, **Project Management**, and **CMO interaction**.
- Familiarity with late-stage drug development and Health Authority expectations.
- Experience in tech transfer, scale-up, process validation, and regulatory document preparation.
- Strong leadership and people management skills.
- Skilled negotiator focusing on mutual benefit.
- Collaborative approach with excellent relationship building and influencing abilities.
- Proficient in written and spoken English.

We guarantee absolute confidentiality during our discussions.