The Senior Manager, Microbiology is responsible for leading microbiology laboratory operations, ensuring the quality, safety, and compliance of microbiological testing programs. This role provides strategic and technical leadership for environmental monitoring, microbial identification, sterility assurance, and method validation activities while maintaining adherence to regulatory requirements and industry standards. The Senior Manager oversees laboratory personnel, drives continuous improvement initiatives, supports audits and inspections, and collaborates cross-functionally with Quality, Manufacturing, R&D, and Regulatory teams to ensure product quality and business objectives are achieved. Strong leadership, microbiological expertise, and experience in regulated environments are essential for success in this role.
The responsibilities:- Manage the microbiological testing and disposition of finished product, in-process, stability testing,
- validation, and raw material samples.
- Oversee the company's environmental monitoring, sterility testing, and critical utilities monitoring
- program in all GMP aspects. Responsible for the evaluation of manufacturing environment against
- international standards of operation.
- Evaluation of test methods against current USP and industry regulatory standards.
- Review and approve reports, investigations, validations required by company.
- Ensure GMP compliance of all functions and processes of the laboratory and for continuous
- improvement.
- Coordination and evaluation of media fills.
- Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting
- performance objectives and development plans.
- Ensure resource availability to adequately support Manufacturing operations.
- Develop and adhere to department budget.
- Implement quality systems to reduce product testing time and increase timely response to customer
- requirements.
- Prepare, review and implement SOPs and verify documents required
- Assist clients with interpretation of results and facilitate their understanding of testing and data.
- Conduct training in lab quality assurance procedures
- Participate in regulatory and client audits as Subject Matter Expert
Required qualifications:- Bachelor's degree required. Microbiology degree preferred
- Minimum of 7 years experience in a pharmaceutical QC role
- 3 years in a management role
- Experience with Validation/Sterility Assurance issues such as autoclave/dry heat oven validations, biological indicators, objectionable organism investigations/remediations, and plant systems such as HEPA filtration and clean room design desirable
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE,
- BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements: - Duties may require overtime work, including nights and weekends.
- Position requires sitting for long hours, but may involve walking or standing for periods of time.
- Use of hands and fingers to manipulate office equipment is required.
- Wear all PPE required by EHS (typically safety glasses, lab coat, gloves but may include a respirator).
In return, you'll be eligible for[1]
:- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
DisclaimerThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
