Senior Microbiology Manager: GMP Leadership & Sterility

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with  %

Time Off Program

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions, with facilities in Bloomington, IN, seeks a Senior Manager, Microbiology to lead the microbiology laboratory operations ensuring quality, safety and regulatory compliance. You will provide strategic leadership for environmental monitoring, sterility, and method validation, while guiding the team and cross-functional partners to meet product quality and business objectives.

The role requires a strong microbiology background, GMP experience, and the ability to drive

Qualifications

• Bachelor’s degree in a related field; microbiology preferred.
• 7+ years in pharmaceutical QC with strong regulatory experience.
• 3+ years in a management role leading teams and projects.
• Experience with validation, sterility, HEPA, and clean rooms desirable.
• Proficient with enterprise software and MS Office for data and reports.

Responsibilities

• Lead microbiology lab operations to ensure quality and compliance.
• Oversee environmental monitoring and sterility testing.
• Drive continuous improvement and audits across the lab.
• Collaborate with Quality, Manufacturing, R&D and Regulatory teams.
• Hire, coach, and develop lab staff; conduct annual reviews.
• Develop and manage the microbiology department budget.
• Implement GMP-compliant quality systems and SOPs.
• Provide SME support for client data interpretation.
• Coordinate and evaluate media fills; ensure resource readiness.

Skills

Leadership

Regulatory compliance

Quality assurance

Communication

Education

Bachelor’s degree

Microbiology degree

Tools

JDE

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Simtra BioPharma Solutions, with facilities in Bloomington, IN, seeks a Senior Manager, Microbiology to lead the microbiology laboratory operations ensuring quality, safety and regulatory compliance. You will provide strategic leadership for environmental monitoring, sterility, and method validation, while guiding the team and cross-functional partners to meet product quality and business objectives.

The role requires a strong microbiology background, GMP experience, and the ability to drive