- Oversee department activities of up to 15 staff conducting bioburden, endotoxin, sterility, particulate, and container closure testing for raw materials, in-process materials, drug substances, and finished drug products
- Oversee daily operation and address lab needs. Monitor test schedule, progress, data, and work quality. Assist in prioritization as needed.
- Project the staffing, space, and equipment needs for the group
- Identify areas of process improvement to ensure compliant and efficient laboratory operation
- Establish both group and individual goals; manage performance throughout the year by providing regular feedback. Perform annual performance appraisals
- Review, evaluate, and approve SOPS, studies, change controls, and investigation reports
- Ensure current methods meet evolving regulatory requirements. Facilitate the remediation of any gaps
- Conduct trouble-shooting and OOS investigations. Implement CAPA as required
- Assist MFG and Facility to solve microbiology related deviations/issues;
- Maintain project timeliness (i.e. implementation of new equipment, methods, etc.);
- Represent QC during regulatory inspections. Respond and address microbiology deficiencies as required.
- Experience leading a Quality Control product testing group in the pharmaceutical industry with experience in parenteral manufacturing. Solid oral dosage and/or Biologics experience a plus.
- Experience with sterility, bioburden, endotoxin, particulate, and CCI testing.
- Microbiology subject matter expert exhibiting technical and theoretical understanding of microbiological methods
- Sound knowledge of cGMP, USP, FDA, and international compendial requirements
- Ability to lead and manage a team of individuals in the department to proactively achieve results for the best of the organization.
- Ability to cope with a rapidly changing work environment.
- Commitment to teamwork.
- Commitment to continuous improvement in all areas.
- Ability to focus attention to details and ensure high quality work while maintaining the big picture to lead/drive whole organizational success.
- Ability to work safely; seek out and encourage safe practices.
Education and Experience:
- Requires BS/BA in microbiology or closely related field.
- Strong leadership skills and managerial experience with a minimum of 5 years of microbiology laboratory management experience and minimum 10 years working experience in microbiology lab preferred in pharmaceutical or biotech industry.