Proclinical is seeking a Senior MSAT Project Manager to support late-stage process development, characterization, and validation efforts for pharmaceutical manufacturing. This role offers the opportunity to work in an innovative and growing field, contributing to clinical supply, process development, and new product introductions. The position is based in Jura, Switzerland, with flexible work arrangements, including potential remote work.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Oversee the execution of late-stage process development, characterization, and validation projects within set timelines and budgets.
- Collaborate with cross-functional teams, including MSAT, analytical development, manufacturing, and quality control, to develop and implement process validation, qualification, and monitoring plans.
- Lead a team supporting the product portfolio, ensuring efficient processes, knowledge sharing, and integration of lessons learned.
- Ensure compliance with relevant regulations and support regulatory submissions by creating source documents and reviewing CMC packages for filings such as IND, BLA, and MAA.
- Provide project leadership for new product introductions, process transfers, and process improvements through change control processes.
Key Skills and Requirements:
- Strong knowledge of GxP compliance and data integrity principles.
- Proven experience managing complex CMC drug product fill-finish projects, with expertise in biologics process development, transfer, and validation preferred.
- Proficiency in English, both written and verbal; French is a plus.
- Familiarity with project management tools and methodologies.
- Advanced degree (Master's or PhD) in Biology, Bioengineering, Biotechnology, or a related field.
- Experience in biotechnology project management or leadership roles, particularly in aseptic processing.
- Background in small to mid-sized pharmaceutical companies is advantageous.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
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