Manager, Quality Control Microbiology

About the role

The Manager, Quality Control (QC) Microbiology will ensure the QC Microbiology laboratory is operating as expected. This individual will partner and collaborate with Facilities to ensure equipment maintenance and calibrations timelines are met. She/he will ensure the laboratory housekeeping activities are completed to maintain the QC Microbiology in a state of compliance.

Responsibilities

• Lead, manage and develop QC microbiology team members.
• Schedule and coordinate laboratory activities including but not limited to release testing of final products, stability testing and release testing of microbiology materials and reagents ensuring adherence to turn‑around‑times.
• Draft, review and/or approve microbiology verification or qualification protocols and reports to support introduction of microbiology platform methods for new products.
• Author, review and/or approve microbiological test methods and procedures.
• Support technical conversations with internal and external customers related to microbiology methods.
• Assist in understanding and/or solve technical problems related to QC Microbiology issues.
• Author, review and/or approve Deviations, CAPA and Changes Controls, as assigned by QC Director.
• Oversight of the site’s environmental monitoring and utility monitoring programs.
• Establishment of environmental monitoring programs as it relates to new product introduction including oversight of performance of environmental monitoring risk assessments, environmental monitoring performance qualifications and establishment of operational environmental monitoring requirements.
• Responsible for environmental monitoring activities including but not limited to scheduling, authoring/reviewing/approving procedures, data, reports and/or risk assessments, as needed.
• Review and approval of sample testing and analysis of manufactured products using microbiological methods (rapid ATP detection, endotoxin detection, and mycoplasma detection by qPCR).
• Coordinate with Supply chain on material management for the QC Microbiology team, including routine needs as well as requirements for qualification/validation/verification activities.
• Understand the requirements, expectations and needs of internal and external customers and interact in a courteous, professional, supportive and collaborative manner.
• Support additional Quality initiatives, as needed.

Requirements

• Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related scientific discipline.
• 5+ years of progressive QC Microbiology experience within biotechnology, pharmaceutical, cell therapy, or another cGMP‑regulated environment.
• Prior experience leading, supervising, or developing laboratory personnel.
• Strong knowledge of cGMP requirements, microbiological testing, environmental monitoring, and applicable regulatory guidelines.
• Experience overseeing environmental and utility monitoring programs within a GMP manufacturing environment.
• Experience with microbiological method qualification, validation, verification, and method implementation.
• Experience with product release and microbiological safety testing, including methods such as endotoxin, mycoplasma, and rapid microbiological testing.
• Experience authoring, reviewing, and approving SOPs, protocols, reports, test methods, and other controlled laboratory documentation.
• Experience supporting deviations, investigations, CAPAs, change controls, and root cause analysis.
• Strong laboratory planning and organizational skills with the ability to manage testing schedules, priorities, and turnaround times.
• Strong technical communication and problem‑solving skills with the ability to collaborate across Manufacturing, Quality, Facilities, Supply Chain, and other functions.
• Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards.
• Must be willing to be gown qualified and work in BSL‑2 lab/CNC/ISO7/ISO8 facility.
• Must be able to lift and carry up to 30 lbs.
• Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.
• Must be willing to sit or stand for extended periods.
• Must be willing to work with cell‑based products, chemicals or hazardous materials.
• Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments. May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials. Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements. May require occasional work outside of normal business hours to support maintenance needs or facility emergencies. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.