Senior Manager, Microbiology & GMP Excellence

Simtra US LLC; Bloomington (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2x

Time Off & Holidays

Job summary

Simtra BioPharma Solutions is seeking a Senior Manager, Microbiology to lead microbiology laboratory operations, ensuring quality, safety and compliance of testing programs. You will provide strategic direction for environmental monitoring, microbial identification, sterility assurance and method validation, while aligning with Quality, Manufacturing, R&D and Regulatory teams.

The role requires strong leadership, microbiology expertise, and experience in regulated environments to drive

Qualifications

• Bachelor's degree required; Microbiology degree preferred.
• Minimum of 7 years experience in a pharmaceutical QC role.
• 3 years in a management role; leadership experience.
• Experience with Validation/Sterility Assurance issues and plant systems.
• Computer proficiency in MS Word/Excel/Outlook and enterprise software (JDE, BPLM, Pilgrim, Trackwise).

Responsibilities

• Manage microbiological testing and disposition of finished product, in-process, stability testing, validation, and raw material samples.
• Oversee environmental monitoring, sterility testing, and critical utilities monitoring program in GMP.
• Evaluate manufacturing environment against international standards of operation.
• Evaluate test methods against USP and regulatory standards.
• Review and approve reports, investigations, validations per company.
• Ensure GMP compliance and drive continuous improvement in the laboratory.
• Coordinate and evaluate media fills; supervise staff hiring and development.
• Manage department budget and allocate resources for manufacturing operations.

Skills

Microbiology

GMP

Team leadership

Regulatory compliance

MS Office & Enterprise software

Education

Bachelor's degree

Microbiology degree preferred

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions is seeking a Senior Manager, Microbiology to lead microbiology laboratory operations, ensuring quality, safety and compliance of testing programs. You will provide strategic direction for environmental monitoring, microbial identification, sterility assurance and method validation, while aligning with Quality, Manufacturing, R&D and Regulatory teams.

The role requires strong leadership, microbiology expertise, and experience in regulated environments to drive