Manager/Senior Manager, Quality Control - Microbiology

Genezen•Lexington, MA

About The Position

Genezen is seeking a Manager/Senior Manager, Quality Control - Microbiology to manage the Microbiology laboratory and its personnel and oversee the site Environmental and Personnel Monitoring program. The position requires strong, hands-on technical experience with microbiological assays, including Endotoxin, Bioburden, and TOC, as well as Environmental Monitoring. The Manager provides microbiology expertise, ensures adherence to cGMP/GMP policies and SOPs, and communicates effectively across departments. The role also champions continuous improvement within the Microbiology team and the broader QC organization. The position oversees day-to-day QC Microbiology operations, laboratory compliance and safety, personnel development, testing and monitoring programs, laboratory investigations and quality systems. It collaborates with QC Technical Services and cross-functional teams on method validation, stability studies, equipment implementation, inspections, and site improvement initiatives. The position may be based at Genezen’s Fishers, Indiana or Lexington, Massachusetts location. Compensation depends on experience: Manager, $130,000–$150,000; Senior Manager, $150,000–$170,000.

Requirements

Bachelor of Science in Microbiology, Biology, or a related scientific discipline.
At least 8 years of GMP Quality Control experience, including at least 4 years of management experience.
Advanced knowledge of global GMP guidelines, especially US and EU guidelines.
Strong leadership in team management, decision-making, change management, collaboration, delivering business results, and influencing others.
Confident, independent, proactive, self-starting, and results-oriented, with high performance and compliance standards.
Ability to prioritize and work with a sense of urgency.
Strong organizational, analytical, and problem-solving skills.
Effective communication and interpersonal skills, with the ability to interact with stakeholders at all levels.
Ability to solve problems and implement practical solutions in a dynamic and innovative environment.
Strong operational and business acumen.
High integrity and commitment to ethics and compliance.
Openness and transparency in sharing data and information.
Adaptability, as work schedules may change based on business needs.
Successful completion of a criminal background check and drug screen.
Ability to meet the stated physical demands, including regular extended sitting; frequent standing, use of hands, reaching, lifting or moving up to 10 pounds, close-vision work, and communication by talking, hearing, telephone, and email; occasional walking, climbing or balancing, stooping, kneeling, crouching, crawling, and lifting or moving up to 25 pounds.

Responsibilities

Maintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOPs, guidelines, and regulations.
Coordinate day-to-day QC Microbiology operations, including activity and resource planning, performance guidance and reviews, and cross-functional communication.
Manage and develop direct reports by setting goals, providing performance feedback, supporting career development, and recognizing strong performance.
Oversee testing of in-process samples, drug substance and drug product release and stability samples, and complaint samples.
Oversee environmental and utility monitoring in accordance with SOPs, sample test requests, approved protocols, and investigations.
Maintain high standards of data integrity; oversee timely investigations of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA.
Maintain critical reagents, controls, and laboratory supplies.
Manage outsourced testing activities as needed and ensure results are reported in a timely and compliant manner.
Develop, maintain, and continuously improve QC systems for sample management, testing, data approval and management, data archiving, and QC equipment validation and calibration.
Participate in cross-functional continuous-improvement projects that support site improvements and cost efficiency.
Support and participate in internal and external audits and inspections, including regulatory inspections.
Collaborate with QC Technical Services on method validation, specification generation, stability studies, and life-cycle management of methods, reference standards, and critical reagents.
Support validation and implementation of new equipment.
Provide QC data internally and participate in cross-functional teams, including CMC, Quality Management, Management Review Meetings, and SRB.
Escalate issues promptly to Quality senior management and cross-functional support teams.
Perform other duties as assigned.