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Manager Microbiology – Product Testing

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Location
Cincinnati, OH
Job Type
Direct Hire
Date
Jun 11, 2019
Job ID
2669736

Manager, Microbiology – Product Testing


The Manager of the Microbiology laboratory (Product Testing) is responsible for managing the product testing group.  This team completes the bioburden, endotoxin, sterility, and particulate testing for raw materials, in-process, drug substance, and finished drug products.  Ensures department metrics and cycle times are monitored and achieved.


This managerial role includes managing the performance of employees, temporaries, and contractors, which will include: objective setting, performance reviews, staffing, corrective actions, succession planning, training and development.


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.