Beschreibung
Drug product project leader (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- 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
- Provide Guidance to junior drug product development scientists and project leaders globally ensuring project management and scientific excellence within the organization
Main qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
- 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 fluency
Main advantages:
- Work in multidisciplinary and international teams, reporting scientific/technical results internally and representing externally at meetings, giving talks, being part of industry consortiums, publishing papers.
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
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