Microbiology Supervisor

SCIENTECH LABORATORIES – MICROBIOLOGY LAB SUPERVISOR

The Microbiology Lab Supervisor is responsible for establishing standard operating procedures (SOPs), developing efficient work processes, managing lab workflow, personnel, and deliverables in a cGMP microbiology laboratory responsible for testing OTC drug raw materials and finished products, pharmaceuticals, and other products for various clients.

Responsibilities

·      Build and manage Microbiology lab, workflow, personnel, and deliverables in a cGMP-compliant analytical laboratory responsible for testing OTC drug, dietary supplement, cosmetic, and Rx Pharma products.

·      Establish Microbiology Lab best practices (USP), SOPs, work processes, work flow, and reporting templates consistent with USP , , & , bioburden, and related microbial testing protocols.

·      Manage the validation of alternative microbiological methods in accordance with USP , as well as the transfer to other facilities.

·      Serve as Scientech Microbiology subject matter expert (SME).

·      Write and review standard operating procedures and coordinate method development and validation of microbiological and analytical methods

·      Identify best vendors for equipment, reagents, and disposables to install and establish Microbiology Lab capabilities.

·      Coordinate and support IQ/OQ/PQ, calibration, and maintenance of microbiology laboratory equipment and instrumentation.

·      Produce quality data for testing results across multiple microbiology methods and platforms. Provide daily quality control data review of results coming from Microbiology Lab.

·      Perform initial identification of microbial contaminants and/or isolates

·      Represent the Microbiology Lab in internal, client, and regulatory body audits

·      Hire, train, and manage Microbiology Lab staff, including annual reviews

·      Oversee laboratory daily operations, people and processes to assure timely deliverables.

·      Lead troubleshooting of all Microbiology Lab issues. Conduct investigations regarding out of specifications (OOS) results and address/manage deviations related to microbiology procedures.

Qualifications

·      MS in Microbiology preferred, Biology and other Life Sciences degrees acceptable, with 3+ years Microbiology Lab experience with significant people and process responsibility in an FDA cGMP-regulated environment. Or,

·      BS with 8+ years experience will be considered with 5+ years experience managing people, developing and running methods in a Microbiology Lab in an FDA cGMP-regulated environment.

·      Experience maintaining and troubleshooting a broad array of Microbiology lab methods, instruments, and equipment.

·      Knowledgeable and proficient in bioburden, endotoxin, microbial identification and industry environmental monitoring requirements/guidelines.

·      Proven independent worker, program builder, and problem solver.

·      Proven ability to work in high stress, rapid growth environment.

·      Excellent people, communication, and leadership skills.

·      Able to prioritize routine tasks and adapt to a changing environment.