Drug Product Project Leader
Posted on Apr 6, 2022 by Michael Bailey Associates - Zurich
Job Title: Drug product project leader
Senior Expert Science & Technology - Drug product project leader in Biologics Development - Basel, Switzerland
As a drug product project leader you will play a key role in the development of formulations and processes for parenteral dosage forms of Biologics (eg monoclonal antibodies, therapeutic proteins, conjugates and other new modalities) for clinical or commercial use.
You will be working in an international team at our headquarters in Basel, Switzerland and help to bring innovative treatments to patients and global markets around the word. Apply now to join our dynamic team!
- As Drug Product Project Leader you will be the strategic lead of Drug Product Development within Biologics projects and be accountable for agreed upon deliverables to the CMC team
- Lead and co-ordinate the global drug product sub-team (functional experts from eg Formulation and Process Development, Analytics, Production, Devices or Regulatory) and represent Drug Product Development on the global CMC team.
- Author or review regulatory CMC documents and communicate with health authorities, if required
- Oversee and contribute to design, planning, performance and interpretation of scientific experiments for the pharmaceutical development of stable liquid and lyophilisate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process; upscale and transfer of processes and support if process validation and registration of the product
- Responsible for resource and budget planning of drug product development activities internally and externally.
- Proactively communicate project strategy and resource demand. Adapt project strategy and prioritize project activities as needed.
- You will be working in multidisciplinary and international teams, reporting scientific/technical results internally and representing the client externally at meetings, giving talks, being part of industry consortiums, publishing papers.
What you'll bring to the role:
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
- Minimum of 2-5 years of successful experience in biotech/pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
- Experience in protein analytics, lyophilization, primary packaging development for biologics as well as regulatory submissions is an advantage.
- Excellent scientific leadership skills, interdisciplinary thinking and proven ability to work in cross-functional, international teams.
Strong presentation skills and scientific/technical writing skills.
- English Fluent, German a plus
Michael Bailey International is acting as an Employment Business in relation to this vacancy.