We are looking for a Process Validation Expert to take charge for writing process validation reports to support BLA (Biologics License Application) for regulatory approval.
Education (minimum): BSc. in Chemistry, Pharmacy,
Thorough understanding of biotech manufacturing processes within USP and/or DSP.
Experience in process validation.
Expertise in writing technical reports in English
Expertise in regulatory affairs and compliance specifically to process manufacturing of biologics( monoclonal antibodies)
Writing and reviewing validation and manufacturing reports for biotech drug substance manufacturing processes (such as Upstream and Downstream)
Analyze and evaluate data and information from executed validation studies.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.