Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you’re passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.
Position Summary
The Lead, QC Microbiology Analyst (1st shift, Sunday-Wednesday 6:30am to 5pm) will oversee daily operations, including workflow adjustments, test execution, and adherence to quality standards. This role is hands-on, requiring the individual to conduct Environmental Monitoring testing, monitor EM samples, and ensure gowning qualifications while preparing samples in a cleanroom setting. This role will coordinate and support the staff, indirectly, to ensure compliance with cGMP standards and to establish key performance indicators, all while maintaining microbiological quality control and technical standards.
Essential Functions and Responsibilities
The following outlines the key responsibilities associated with the role. This summary does not encompass all tasks, duties, skills, efforts, requirements, or working conditions related to the position. While it aims to accurately represent the current job, management retains the authority to modify the role or assign additional tasks as needed, with or without prior notice.
Deliver technical and compliant guidance to indirect team members for their daily operations.
Draft, review, and authorize documentation including EM trend reports, EM Lot Release, Deviations, CAPA, SOPs, Work Instructions, Forms, Protocols, and various reports including any quality system support.
Evaluate and approve Facility shutdown documentation.
Conduct Environmental monitoring, Plate readings, Growth Promotions, and Microbial Identifications. • Manage lab inventory, MSID, Sterility scheduling support, and triage meetings.
Uphold compliance with regulatory agency standards by fostering a quality culture within the department.
Provide trending data and assist in troubleshooting MODAs.
Suggest process enhancements to improve efficiency within the department and across sites.
Engage in departmental and cross-functional meetings, serving as a Subject Matter Expert during audits
Ensure audit readiness in the department by providing adequate staff training, reviewing documentation, and maintaining laboratory cleanliness and walkthrough
Collaborate with internal and external customers to facilitate proper sampling, reporting, and addressing inquiries and concerns.
Monitor and support sitewide directives related to KPIs and metrics
Review the real time EM data for static and dynamic
Manage Tier meetings and provide actionable feedback.
Create work orders, purchase orders, manage inventory and oversee alarms for the area
Learn the new methods and techniques to support the functional area
Perform additional duties as assigned.
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
Leadership Responsibility
May Indirectly supervises 5-6 QC Microbiology Analyst in the QC Microbiology department.
Train and mentor Analyst I, Analyst II, Analyst III
Knowledge, Skills & Ability
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of microbiological test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software with MS Office and LIMS (MODA experience preferred).
Proficient with computer software such as a Microsoft Office, MODA and Visio etc
Candidate must be familiar with ISO and EU classified environments Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
Education & Experience
Bachelor’s degree in a Microbiology or relevant field
Minimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Shift: 1st shift, Sunday-Wednesday 6:30am to 5pm
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more

Please refer the Job description for details