Process Validation Expert - Biotech Products

  • Michael Bailey Associates - Munich
  • Basel, Switzerland
  • Oct 31, 2017
Contractor Biotech Science

Job Description

We are currently looking for a Process Validation Expert to validate biotech drug products. For this role you will need a thorough understanding of manufacturing processes for both upstream (USP) and downstream processing (DSP) as well as in regulatory affairs (S25). This is a 9 month contract role, with possibilities of extension highly likely.

Job description

Please note that no sponsorship is available, thus candidates will have to have no restrictions on their eligibility to work in Switzerland.

Responsibilities:

  • You will write process validation reports which will serve as source documents for a BLA (Biologics License Application).
  • Author process validation reports for biotech drug substance processes (Upstream and Downstream).
  • Analyze and evaluate process data from executed validation studies.

Basic Requirements:

  • MSc or BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.
  • Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
  • Experience in process validation.
  • Expertise in writing technical reports in English
  • Experience in regulatory affairs particular in writing module S25.
  • English & German fluent.

Please send CVs or call.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.