Manager, Quality Control Microbiology

Made Scientific, Inc.; East Norriton Township (Montgomery County); Presencial; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

Made Scientific, Inc. is seeking a Manager of Quality Control (QC) Microbiology to lead the QC microbiology laboratory, partner with Facilities to meet calibration timelines, and ensure housekeeping is maintained in a state of compliance.

The role covers release and stability testing, environmental monitoring oversight, deviation handling, CAPA processes, and SOP management within a GMP cell-therapy CDMO environment. Strong leadership and cGMP expertise are required.

Qualificações

• Bachelor's degree in Microbiology, Biology, Life Sciences or related scientific discipline required.
• 5+ years of progressive QC Microbiology experience in biotech, pharma, cell therapy, or other cGMP environment.
• Experience leading or developing laboratory personnel.
• Strong knowledge of cGMP, microbiological testing, environmental monitoring, and regulatory guidelines.
• Experience with environmental/utility monitoring in GMP manufacturing.
• Experience with microbiological method qualification, validation, verification, and implementation.
• Experience with product release and microbiological safety testing (endotoxin, mycoplasma, rapid methods).
• Experience authoring/reviewing SOPs, protocols, reports, and controlled lab documents.
• Experience supporting deviations, investigations, CAPAs, change controls, root cause analysis.

Responsabilidades

• Lead, manage and develop QC microbiology team members.
• Coordinate laboratory activities including release and stability testing to meet turnaround times.
• Draft/review/approve microbiology verification/qualification protocols and reports.
• Author/review/approve microbiological test methods and procedures.
• Support technical conversations with internal and external customers on microbiology methods.
• Assist in solving technical QC Microbiology issues.
• Author/review/approve deviations, CAPA and changes controls as needed.
• Oversee environmental monitoring programs.
• Establish environmental monitoring for new product introductions and risk assessments.
• Schedule, document, and report environmental monitoring activities and data.

Conhecimentos

Leadership

cGMP knowledge

Microbiology testing

Environmental monitoring

SOPs & docs

Cross-functional collaboration

Formação académica

Bachelor's degree in Microbiology or Life Sciences

Descrição da oferta de emprego

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

Position Summary

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.

Key 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.

Required Qualifications

• 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.

Preferred Qualifications

• Experience within cell therapy, gene therapy, biologics, or aseptic manufacturing.
• Experience working within a CDMO and interacting directly with external clients.
• Experience with technical transfers and new product introduction.
• Experience establishing or expanding environmental monitoring programs, including risk assessments and performance qualification.
• Experience with rapid microbiological methods, qPCR, ATP detection, endotoxin testing, and other advanced microbiology technologies.
• Experience supporting regulatory inspections, client audits, and laboratory inspection readiness.

Physical Requirements

• 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 Environment

• 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.

Equal Employment Opportunity Statement

Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law.

Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.