- Managementof all microbiology and chemistry testing associated with the start-up, validation, and on-going commercial operation of the manufacturing facility.
- Management of lab investigations of out-of-specification or non-conforming results and management of follow-on CAPA's, as needed.
- Management of analytical method transfer into the facility, or to contract labs, as needed.
- Management of product testing through outside labs, for lab functions which may be performed by third party labs.
- Degree in Science (Chemistry, Microbiology or Pharmaceutical Sciences)
- 10+ years experience working in pharmaceutical chemistry or microbiology laboratories
- 5+ years experience in management of pharmaceutical Quality Control laboratories.