Project Lead - Basel, Schweiz - CTC Resourcing Solutions
Beschreibung
Project Lead - Pharma Manufacturing (DP ADA
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a
Technical Project Lead with expertise in Pharma Manufacturing (Drug Product).
You will establish Manufacturing Science and Technology (
MSAT) expertise across different equipment platforms for
Drug Product development & manufacturing with focus on
Parenterals.
This is a
contract based opportunity (1 year) with great chances of extension and based in
Schaffhausen, Switzerland.
Main Responsibilities:
- Ensure timely
plant readiness to support experimental / clinical activities - Ensure timely
delivery of clinical material from internal pilot plants or from external contract manufacturing organizations (CMO) - Manage the overall relationship with internal/external manufactures and act as the single point of contact between the organization and the respective manufacturing site
- Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
- Support scaleup and Tech-Transfer
- Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
- 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
- Ensures 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
- 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 is preferred
- Experience in clinical or commercial manufacturing is required. Prior experience working with a CMO is preferred.
- Ability to collaborate with crossfunctional teams is a must.
- Excellent oral and written language skills in
German and English.
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