Pharma Manufacturing Lead (5312)
Pharma Manufacturing Lead – 5312 ADA
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Pharma Manufacturing Lead.
You will establish Manufacturing Science and Technology (MSAT) expertise across different equipment platforms for Drug Product Development & Manufacturing with focus on /Biologics. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.
This is a contract based opportunity (1 year) with great chances of extension and based in Schaffhausen, Switzerland.
- Ensure timely plant readiness to support experimental / clinical activities
- Ensure timely delivery of clinical material from internal pilot plants (single point of contact of the internal manufacturing site).
- Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
- Support scale-up and Tech-Transfer
- Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
- Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
- Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
- Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
- Prepare business plan forecasts and monitor actual spend vs budget.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- You have a degree in Pharmaceutical/Biochemical/Life Science/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (5+ years) OR a PhD with proven experience (3+ years)
- Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
- Demonstrated proficiency and experience of biopharmaceutical process design is helpful
- Solid understanding and experience of technology transfer operations is preferred
- Solid understanding and experience in fill/finish operations and/or understanding, and experience in device assembly are highly appreciated
- Ability to collaborate with cross-functional teams is a must.
- Fluent in English and at least intermediate communication skills in German are required