For our customer located in Basel/Switzerland we are currently looking for a: Drug product project leader (m/f/d)
- Location: Basel
- Branch: Pharma
- Duration: 10 months
Tasks & Responsibilities
• 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 e.g. 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 external at meetings, giving talks, being part of industry consortiums, publishing papers.
• You will provide guidance to junior drug product development scientists and project leaders globally ensuring project management and scientific excellence within the organization.
Must Haves
• Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
• Minimum of 5-8 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 BLA / MAA submission is an advantage.
• Proven track record in resolving technical issues as well as in the successful leadership of strategic innovation projects
• 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
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
Preferred Interview Dates
- asap