Principal Lead, MST & Ext Manufacturing
On-siteSchaffhausen, Schaffhausen, Switzerland
EXPIREDSchaffhausen, Schaffhausen, SwitzerlandOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Ensure timely readiness of contract manufacturing organizations or internal pilot plants to support clinical activities and manage the overall technical relationship with CMOs as the single point of contact. Deliver clinical material on schedule, provide input to drug product development teams, and support scale-up, technology transfer, and continuous improvement initiatives. Source raw materials, oversee CAPAs and change controls, and prepare business plan forecasts to monitor spending versus budget.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field
- 8+ years of relevant biopharmaceutical experience
- 8+ years of sterile drug product process development and manufacturing experience
- Master's degree
- 6+ years of experience (with Master's degree)
- PhD
- 4+ years of experience (with PhD)
- Demonstrated proficiency and experience in biopharmaceutical process design
- Understanding and experience in fill/finish operations
- Experience in clinical or commercial manufacturing
- Motivated with the ability to work independently with demonstrated problem solving skills
- Ability to collaborate with cross-functional teams
- Prior experience working with a CMO
- Excellent English and German oral and written language skills
- Good CMO relationship management skills
- Good understanding of procurement and legal workflows needed to support contract negotiations and new CMO onboarding
Desired Qualifications
- Proven proficiency and experience in biologics drug product development within the biopharmaceutical industry
- Solid understanding and experience in technology transfer operations
- Proven track record of creativity and problem solving skills
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