MICROBIOLOGY LABORATORY SUPERVISOR

The Microbiological Control (MC) Laboratory supports the onsite small scale commercial manufacturing facility. The Laboratory Supervisor provides oversight and coordination of activities including routine microbiological testing of materials and products for in-process, release and stability purposes within a cGMP compliant area. A variety of duties are performed by the supervisor relating to the efficient and effective functioning of the Microbiological Control lab.

• Supervises the daily operations of the QC laboratory staff, which perform a wide variety of regulatory, compendia microbiological analyses to evaluate raw materials, in-process samples, API, and environmental samples, using aseptic technique and in compliance with established procedures and regulatory requirements.
• Train and schedule technical personnel to assure testing occurs in a manner that is efficient and compliant with cGMPs, compendia requirements, and regulatory expectations.
• Must analyze, evaluate, and interpret data, notifying clients of results and assisting to resolve issues, if applicable.
• Review and approve laboratory documentation associated with testing and investigations.
• Conduct, review and approve microbiological investigations as required.
• Must update and write new procedures, protocols, and technical reports, as required.
• Promotes quality, safety and health, by ensuring clean work area, and adherence to procedures and safety culture by staff.
• Must lead continuous improvement using lean principles to assist with streamlining and making the laboratory efficient.
• The supervisor is responsible for providing feedback, coaching, training, and performance evaluations for each of their direct reports.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Must have knowledge of sterilization and Quality Control microbiological testing and procedures with the application and interpretation of GMP concepts and compendia requirements (USP, EP, JP, TGA and CFR) to daily laboratory operations.
• Must have understanding of methods, equipment and procedures in work area.
• Must have excellent verbal and written communication skills.
• Demonstrates ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner with minimal supervision.
• Must be able to lead, train, and direct work of others to meet objectives of department and company.
  
  Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
  
  B.S. degree in Microbiology, Biological Sciences, or related field with minimum of 7-9 years of QC microbiology laboratory experience; M.S. degree with minimum of 4-6 years of relevant experience.
  
  Physical Demands: (see items to consider on last page)

This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE). This role will require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including acids, and caustics. Powdered materials and high temperature liquids and solids are also handled. Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required. This role also requires frequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hands/wrists and grasping is also required. Depending on the work demands, office-based work requires sitting.