USP Manufacturing Specialist

USP Manufacturing Specialist

Job Title: USP Manufacturing Specialist
Contract Type: Permanent
Location: Reykjavik
Salary: Generous salary and benefits. Details on application.
Start Date: 2019-07-04
Reference: J16289
Contact Name: Alex Butcher
Contact Email:
Job Published: July 10, 2019 17:18

Job Description

An exciting opportunity has arisen USP Manufacturing Specialist to culture mammalian cells aseptically from cell revival stage in shake flask until the end of the production process. You will also prepare media and buffers and write, review and approve SOPs, BMRs and other GMP documentation.
This company is well resourced and financed with significant growth plans. Be part of a company who has established itself as a fully integrated biopharmaceutical company, ranging from cell line development of biosimilars to manufacturing, clinical development and registrations. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy.  Their assets include six biosimilar monoclonal antibodies (mAbs).
Suitable candidates will need to possess skills/experience in the following areas: -

  • Degree in a relevant discipline
  • Knowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products.
  • Hands-on experience operating upstream processing equipment.
  • Knowledge/experience of cell culture principles, techniques, scale up, technology transfer and process validation activities.
  • Knowledge of cGMP compliance and associated documentation.