Position Summary

The Supervisor, Microbiology will report the Director, Microbiology. The incumbent will be responsible for establishing testing timelines, executing the plan, and monitoring the results.

Job Responsibilities

• Assist with writing and implementing SOP's, work instructions and protocols according to cGMP and cGLP.
• Performance and documentation of laboratory investigations.
• Perform internal auditing and assistance in handling of external audits by customers and FDA during departmental review.
• Develop and maintain cryo-stored cell line including in house identified isolates
• Submit purchase orders for equipment and materials.
• Interview potential candidates and onboard new employees.
• Assist with autoclave and depyrogentaion oven validations.
• Generate staff shift and schedules aligned with required QC and manufacturing support functions.
• Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
• Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs daily.
• Perform training on laboratory methods and instrumentation.
• Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter.
• Perform other duties as assigned.

Experience Requirements

• Minimum of five years of experience in a QC Microbiology Laboratory.
• Must demonstrate proficiency in microbiology laboratory techniques such as water analysis by membrane filtration, endotoxin analysis, sterility analysis, and identification.
• Previous supervisor experience or demonstrated skills to lead/mentor a group cohesively and effectively.

Education Requirements Bachelor's degree in Microbiology or related scientific discipline.