Pharma Manufacturing Scientist.

For our client, an international company in Schaffhausen, we are looking for a
Pharman Manufacturing Scientist
 

• Start date: ASAP
• End: 31.12.2023
• Extension: possible
• Workplace: Schaffhausen
• Workload: 100%

In this position, you will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.

Requirements:

1. Ensure timely plant readiness to support experimental / clinical activities
2. Ensure timely delivery of clinical material from internal pilot plants (single point of contact of the internal manufacturing site).
3. Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
4. Support scale-up and Tech-Transfer
5. 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
6. Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
7. Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
8. Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
9. Prepare business plan forecasts and monitor actual spend vs budget.

Must Haves:

• 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 and/or experience in fill/finish operations and/or understanding and experience in device assembly are highly appreciated
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.
• Excellent oral and written language skills in English and German (at least intermediate) are required