Supervisor, Microbiology (2nd shift)

The Supervisor coordinates all activities of the Microbiology laboratory including internal/external bioburden and endotoxin testing activities, growth promotion and biological indicators testing. The role oversees the execution of bioburden, and endotoxin method development. The position oversees the scheduling and execution of bioburden and endotoxin testing and other testing as required. The Supervisor is responsible for the management and training of the Microbiology laboratory team. The individual also writes, reviews and approves SOPs, OOSs, and deviations. This position supervises the daily execution of the contamination control program. The Supervisor is responsible for the operation of the Environmental Monitoring Group, ensuring utilities and facilities are tested according to cGMP requirements. This position supervises the daily operation to support manufacturing activities and is responsible for the review and approval of routine and lot-specific Environmental Monitoring data.

Responsibilities

Coordinates all activities of the Microbiology laboratory including internal/external bioburden and endotoxin testing activities, growth promotion and biological indicators testing; Oversees scheduling and execution of bioburden and endotoxin testing and other testing as required; Manages and trains the Microbiology laboratory team; Writes, reviews and approves SOPs, OOSs, and deviations; Supervises daily execution of the contamination control program; Supervises the operation of the Environmental Monitoring Group ensuring utilities and facilities are tested according to cGMP requirements; Reviews and approves routine and lot-specific Environmental Monitoring data; Acts as subject matter expert for the Microbiology laboratory including bioburden, growth promotion, biological indicators, endotoxin, and water tests; Interacts with Project Managers and clients during audits; Releases batch records; Maintains laboratory performance metrics on a monthly basis

Requirements

Bachelor’s Degree in Life Sciences field or equivalent experience required; Minimum five (5) years of experience in Microbiology; Minimum of 1 year of supervisory experience; Ability to supervise and motivate laboratory personnel; In-depth knowledge of microbiological methods and techniques; Excellent verbal and written communication skills; In-depth knowledge of Environmental Monitoring and contamination control

Benefits

Eligibility for an annual performance bonus; Paid time off; Health insurance coverage including dental and vision; Flexible spending account; 401(k)