Pharma
Drug Product Project Leader – CMC
Switzerland / Contract
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Drug Product Project Leader – CMC vacancy for our Basel based client in the Pharma sector.
Your tasks:
- Lead and co-ordinate the global drug product sub-team and represent Drug Product Development on the global CMC team.
- Ensure adherence to scientific and project review processes through relevant governance boards.
- Create high-quality and scientifically sound drug product development documents.
- 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 lead and manage key scientific initiatives to develop short & long term drug product development strategies for a large NBE pipeline within global drug product development
- You will provide guidance to junior drug product development scientists and project leaders globally ensuring project management and scientific excellence within the organization.
- You will be working in multidisciplinary and international teams, reporting scientific/technical results internally and representing externally at meetings, giving talks, being part of industry consortiums, publishing papers.
- Author or review regulatory CMC documents and contribute to the generation of filing dossiers.
- Responsible for resource and budget planning of drug product development activities.
Your experience/knowledge:
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent.
- Minimum of 5 years of experience in biotech/pharma industry with emphasis on biologics drug product formulation and process development.
- 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.
- Language skills: English
Your soft skills:
- Excellent scientific leadership skills, interdisciplinary thinking and proven ability to work in cross-functional, international teams.
- Strong project management skills, ability to solve complex problems in a matrix system with excellent communication and negotiation skills
- Strong presentation skills and scientific/technical writing skills.
Location: Basel, Switzerland
Work setting: On-site
Sector: Pharma
Start: ASAP
Duration: 24+ months
Workload: 100%
Ref.Nr.: BH 23432
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, and current work-permit holders for Switzerland.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.