Microbiology Manager Quality Control
Will be responsible for management oversight of the Microbiology Division to the Quality Control department. Requires a strong working knowledge of and experience with regulatory requirements for Environmental Monitoring of GMP clean rooms including how to appropriately and effectively complete investigations of excursions, familiarity with compendial microbiological safety testing methods and requirements common to the pharmaceutical industry for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.).
BS or higher degree with 7‐10 years of relevant Microbiology experience.
Experience performing and managing performance of Environmental Monitoring of GMP
clean rooms (scheduling and staff, etc.).
Familiarity with state‐of‐the‐art methodology for rapid detection of microbial contamination
and/or identification (BacT/ALERT, Milliflex, MICROSeq, etc.)
Experience with PCR‐based mycoplasma detection assays and validation of such according to
pharmacopeial (e.g. EP) guidelines