Director CMC Cell & Gene (m/f/d)
What you have to offer:
- Advanced degree (Ms/PhD) in Science (Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology) with at least 5 years of relevant industry experience in biologics development, preferably in the field of cell based therapeutics/ATMPs.
- Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing). Documented experience in CMC regulatory affairs would be a plus
- In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development;
- Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus
- Prior experience in project leadership or people management paired with the ability to engage cross-functional teams
- Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management;
- Experience defining and executing strategy is required
- A regulatory background and/or experience in writing of regulatory documents (IND/IMPDs) for clinical stage or marketed products would be a plus.
Your main responsibilities are:
- Collaborate with technical leads and expertise areas (Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Commercial) to develop detailed CMC project plans required to successfully progress an asset from pre-clinical through clinical phases specifically in the field of cell based therapeutics (ATMPs)
- Lead the scientific assessment of development programs related to all CMC aspects as the CMC project lead
- Manage CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective program execution
- Promote timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners to inform product development
- Drive continuous improvement of process and data quality, through streamlining and optimizing processes as well as automation and digitalization