As an industry leader in product safety and quality, our growing client produces a variety of inhalation solutions (OSD, sterile, blow-fill) and is currently working on research and development projects allowing for large expansion to their North Carolina site in the near future. The company’s global presence will make them a top USA pharmaceutical manufacture soon.
Director of Microbiology Role Highlights
- Oversee daily performance of assigned duties for the Microbiology Department, thus providing support to Production, Engineering, and Chemistry Departments and upper management.
- Assists with additional work duties or responsibilities as evident or required.
- Performs other duties as assigned or apparent.
- Manage the overall operations of the Microbiology Department.
- Review / write procedures, test methods, protocols for method validations.
- Oversee and or perform final review of reports, trend reports, or charts generated from testing, or QC functions
- Purchase of required testing materials, equipment, and services.
- Schedule service, maintenance, with outside providers if needed.
- Initiate reports, investigations for trends, OOS, NCRs as required by company.
- Internal, external audits of service, materials, and testing providers.
Background Requirements
Candidate must have a regionally accredited Master’s degree in Microbiology or closely related. Prior Pharmaceutical Industry/Supervisory experience required, minimum of 10 years post academics. Specific expertise, skills and knowledge within an injectable facility highly desired.
- Current knowledge of USP guidelines, cGMP, Aseptic Processing, Aseptic Environmental Monitoring techniques and methods, Microbiological quality control testing.
- The ability to manage a multitude of resources and to be accurate and current with data and information.
- Computer literate: MS Word, Access, and Excel
- Must be willing to move to the Charlotte, North Carolina region with a suggested start date in the fall (September optimal/October suitable).
