About the job
We are partnering with a leading biopharmaceutical company to seek a Director of Drug Substance Technology Transfer to join their expanding Biologics Centre of Excellence. This company is dedicated to innovation and excellence in drug development, with a strong focus on advancing biologics manufacturing.
Key Responsibilities
Technical & Scientific Leadership:
- Lead technology transfer initiatives across internal and external manufacturing networks.
- Oversee process characterization, engineering, performance, and regulatory support across multiple modalities.
- Drive excellence in Tech Transfer execution for Drug Substance.
Project & Portfolio Management:
- Serve as the primary interface between Manufacturing Operations and the broader Drug Substance Technology team.
- Ensure successful delivery and handover of technology transfers.
- Collaborate with Technical Development, Services, and Operations to support product development and commercialisation strategies.
Leadership & Team Development:
- Build, lead, and develop a high-performing team of scientists and engineers.
- Manage project portfolios and engage key stakeholders.
- Foster collaboration, innovation, and adherence to organisational values.
- Support GMP audits and regulatory discussions.
Qualifications & Experience
- 10+ years in the pharmaceutical industry, including managerial experience.
- Proven expertise in Drug Substance Technology Transfer.
- Strong knowledge of Drug Product, Small Molecules, and Business Acumen.
- Experience with CAPA, FMEA, RCA in a regulated manufacturing environment.
- Effective leadership, decision-making, and communication skills.
- Degree in Engineering, Science, or Business
- Willingness to travel (20-30% within Europe).
This role integrates scientific, engineering, and operational leadership, requiring deep expertise in cGMP and Quality Systems within commercial manufacturing processes.