Senior Microbiology Leader - GMP Quality & Compliance

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2?

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, seeks Senior Manager, Microbiology to lead microbiology lab operations, ensuring quality, safety, and regulatory compliance.

You will provide strategic and technical leadership for environmental monitoring, sterility assurance, and method validation, while guiding cross-functional teams and audits.

Applicants should have a bachelor’s in microbiology or related field, 7+ years in pharma QC, 3+ years in management, and hands-on GMP experience.

Qualifications

• Bachelor’s degree required; microbiology degree preferred.
• 7+ years of experience in a pharmaceutical QC role.
• 3+ years in a management role.
• Experience with Validation/Sterility Assurance issues such as autoclave/dry heat validations, biological indicators, investigations/remediations, and plant systems like HEPA filtration and clean room design desirable.
• Proficiency in Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE).

Responsibilities

• Lead microbiology laboratory operations, ensuring quality, safety, and regulatory compliance.
• Oversee environmental monitoring, sterility testing, and critical utilities monitoring program in all GMP aspects.
• Evaluate test methods against current USP and industry regulatory standards.
• Review and approve reports and investigations required by the company.
• Coach, hire, and develop staff; conduct annual performance reviews and establish development plans.

Skills

Management

GMP compliance

Quality systems

Education

Bachelor’s degree

Microbiology degree preferred

Tools

JDE

MS Office

Job description

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, seeks Senior Manager, Microbiology to lead microbiology lab operations, ensuring quality, safety, and regulatory compliance.

You will provide strategic and technical leadership for environmental monitoring, sterility assurance, and method validation, while guiding cross-functional teams and audits.

Applicants should have a bachelor’s in microbiology or related field, 7+ years in pharma QC, 3+ years in management, and hands-on GMP experience.