Biotech Drug Substance Process Validation Expert
Hobson Prior
Switzerland, Switzerland
vor 5 Tg.

Job Title : Process Validation Expert - Biotech Drug Substance

Duration : until end of year, but extension possible if candidate is a good fit.

The validation expert for biotech products is responsible to write process and cleaning validation reports which will serve as source documents for a BLA (Biologics License Application).

Job description :

  • Author process validation and cleaning validation reports for biotech drug substance processes (upstream and downstream).
  • Analyze and evaluate process data from executed validation studies.
  • Prerequisites :

  • Thorough understanding of biotech (mammalian cell based) manufacturing processes and related process equipment (USP and DSP).
  • Experience in process validation.
  • Expertise in reviewing and writing technical reports in English
  • Experience in biotech process validation or biotech cleaning validation (plan and report writing)
  • Experience in regulatory affairs particular in writing module S25 is a plus
  • IMPORTANT : we look for experts in biotech drug substance manufacturing process validation (NOT equipment qualification, not analytical method validation, not computer validation)

    Languages : English fluent (must), German (is a plus)

    Education (minimum) : BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.

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