Drug Product Project Leader (m/f/d)
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 CMC team
- Ensure adherence to the scientific and project review process through relevant scientific and project management governance boards
- Ensure creation of high-quality and scientifically sound drug product development documents enabling a strong CMC submission package
- Act as author, reviewer or approver for development documents in accordance with operational procedures and guidelines
- Author or review regulatory CMC documents, contribute to the generation of filing dossiers, answer drug product-related questions in inspections and support Health Authority requests
- 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
- Lead and manage key scientific initiatives to develop short- and long-term drug product development strategies for a large NBE pipeline
- Provide guidance to junior drug product development scientists and project leaders globally, ensuring project management and scientific excellence
- Work in multidisciplinary and international teams, report scientific/technical results internally and represent the company externally at meetings, through presentations, in industry consortiums, and via publications
Profile
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
- Successful experience in the biotech/pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up and technology transfer
- Experience in protein analytics, lyophilization, and primary packaging development for biologics; BLA/MAA submission experience is an advantage
- Proven track record in resolving technical issues and leading strategic innovation projects
- Excellent scientific leadership skills, interdisciplinary thinking, and ability to work in cross-functional, international teams
- Strong project management skills and ability to solve complex problems in a matrix organization
- Excellent communication and negotiation skills
- Strong presentation skills and scientific/technical writing skills
Benefits
- Start your journey at one of the top Pharma companies in the world
- State-of-the-art working environment with cutting-edge technologies
- Longterm assignment possible
About Hays
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.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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