Do you know any qualified candidates who might be interested in joining a growing company and building a Lab?

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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.

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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<1117>), SOPs, work processes, workflow, and reporting templates consistent with USP <51>, <61>, & <62>, bioburden, and related microbial testing protocols.

· Manage the validation of alternative microbiological methods in accordance with USP <1223>, <1227> 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.

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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.

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