Manager, Microbiology - Product Testing

Alkermes   •  

Wilmington, OH

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 56 days ago

Key Duties:

  • 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.

Skill/Abilities:

  • 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

Personal Attributes:

  • 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.