Manager/Senior Manager, Quality Control - Microbiology

Genezen•Lexington, MA

3d•$130,000 - $170,000

About The Position

Genezen is a gene therapy company that provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. The Manager/Senior Manager, Quality Control - Microbiology is responsible for managing the Microbiology laboratory and its personnel and executing the site Environmental and Personnel Monitoring program. The role requires hands-on technical experience with microbiological assays, including Endotoxin, Bioburden, and TOC, as well as Environmental Monitoring. The manager ensures adherence to cGMP/GMP policies and SOPs, provides microbiology expertise, and communicates effectively across departments. The position also champions continuous improvement within the Microbiology team and QC organization. Genezen operates locations in Fishers, Indiana, and Lexington, Massachusetts; the job description does not specify which location applies to this role.

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 operate 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 standards.
Openness and transparency in sharing data and information.
Adaptability to changes in work schedule based on business needs.
Must complete a criminal background check and drug screen.
Must be eligible to work in the United States; Genezen is unable to sponsor visas.

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 planning activities and resources, guiding and reviewing performance within QC, and maintaining or initiating cross-functional communication.
Manage and develop direct reports by setting goals, providing feedback, supporting career development, and recognizing exceptional performance.
Oversee testing of in-process, drug substance, drug product release and stability, and complaint samples.
Oversee environmental and utility monitoring in accordance with SOPs, sample test requests, approved protocols, and investigations.
Maintain data integrity to the highest industry standards.
Oversee timely investigation of OOS, OOT, and other laboratory exceptions, and manage Deviations, Change Controls, CAPA, 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 supporting site improvements and cost efficiency.
Support and participate in internal and external inspections and audits, including regulatory inspections.
Collaborate with QC Tech Services on method validation, specification generation, stability studies, and lifecycle management of methods, reference standards, and critical reagents.
Support new equipment validation and implementation.
Provide QC data internally and participate in cross-functional teams, including CMC, Quality Management, Management Review Meetings, and SRB.
Escalate issues in a timely manner to Quality senior management and cross-functional support teams.
Perform other duties as assigned.