Senior Analytical Development Manager

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Lonza Biologics Porriño SLU Vollzeit

Join Lonza Biologics Porriño SLU, a global leader in life sciences operating across five continents, and take on the challenge of a dynamic role within our Drug Product Services (DPS) branch.

Key Responsibilities:
  1. Develop and implement analytical strategies for DPS projects: Control strategy from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications and justifications for specifications, analytical method lifecycle (monitoring of performances of platform methods and product-specific methods).
  2. Maintain up-to-date knowledge of assigned molecules, method strategy, industry issues/trends and pharmacopeia as well as adhere to cGMP regulations.
  3. Lead development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing.

The ideal candidate should have a Master degree (PhD is a plus) in Biochemistry, Pharmaceutical Sciences, Analytical Science or related field. At least 5 years of experience working as Analytical and/or QC Project Lead in late clinical phase projects are required.



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