Pharma Manufacturing Scientist

vor 1 Woche


Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

Pharma Manufacturing Scientist (DP ADA


Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a
Pharma Manufacturing Scientist (Drug Product).


You will establish Manufacturing Science and Technology (
MSAT) 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.

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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