Drug product project leader
QLS are recruiting for a Senior Expert Science & Technology - Drug product project leader to join a multinational pharmaceutical company based in Basel, Switzerland, on a contract basis, until the end of April 2023.
The candidate will join theirsite in Basel, Switzerland. His/ her role will be to play a key role in the development of formulations and processes for parenteral dosage forms of Biologics (e.g. monoclonal antibodies, therapeutic proteins, conjugates and other new modalities).Main responsibilities:
- Lead and co-ordinate the global drug product sub-team (functional experts from e.g. Formulation and Process Development, Analytics, Production, Devices or Regulatory) and represent Drug Product Development on the global CMCteam
- Author or review regulatory CMC documents and communicate with health authorities
- Supervise and contribute to design, planning, performance and interpretation of scientific experiments for the pharmaceutical development of stable liquid and lyophilizate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process
- Be responsible for project strategy, resource demand and budget planning of drug product development activities internally and externally.
Candidate’s Requirements:
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
- Previous experience in biotech / pharma industry with emphasison biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
- Experience in protein analytics, lyophilization, primary packaging development for biologics and in regulatory submissions
- Ability to communicate and document in English and German
Apply: Please could you send any correspondence in English. Please quote reference 53612 in all correspondence.