Associate Director Microbiology, BioPharma

3 days left

Employer
Laguna Source BioPharma
Location
Philadelphia County, Pennsylvania, US
Salary
Competitive
Posted
Sep 13, 2021
Closes
Sep 22, 2021
Ref
2453763905
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
This is an exciting opportunity responsible for overseeing Quality Control Microbiology activities within a leading Biologics testing and manufacturing organization. You will be charged with overseeing sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification, site contamination control as well as the following activities: * Overseeing Site Quality Control Microbiology activities within a leading Biologics testing and manufacturing organization. * Leading a team of Managers and Supervisors overseeing sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification and site contamination control activities. * Leading QC Microbiology related Manufacturing Science and technical troubleshooting activities including deviation handling and investigations. * Overseeing contamination control programs such as aseptic processing, environmental monitoring, gowning qualification practices, cleaning, sanitization, disinfection, sterility testing, bioburden testing and the identification of potential microbial contamination. * Providing guidance to clients and customers. * Managing laboratory budgets, departmental budgets and expendatures. * Ensuring Microbiology related Inspection readiness and the hosting of FDA & EMEA audits and inspections.

Job Requirements:
* BS or MS in Microbiology, Biology, Chemistry, Biochemistry or related Life Sciences field. * 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading QC microbiology testing and assays including sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification and site contamination control testing. * Experience leading Microbiology Supervisors and staff. * Expertise leading microbiology related investigations with successful experience resolving related deviations. * Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness. * Expertise leading microbiology related methods development, methods qualification, and methods validation activities.