Senior Microbiologist: GMP Expert & Lab Quality Leader

Piramal Pharma Solutions Inc.

Lexington (KY)

On-site

USD 90,000 - 120,000

Full time

7 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Piramal Pharma Solutions in Lexington is seeking a Senior Microbiologist to serve as the subject matter expert for audits, data review, and lab expansion projects. You will provide technical support to the microbiology team and ensure the lab meets regulatory expectations.

You will prepare and review SOPs, train staff on cGMP practices, lead investigations, and support regulatory inquiries. The role drives continuous improvement in environmental monitoring and testing programs.

Qualifications

B.S. in Microbiology, Biology, Life Sciences, or related field.
5-7 years of experience in high throughput microbiology laboratories in pharma GMP environments.
Experience with Gram staining, isolation plating, media prep and microorganism ID methods.
Experience with autoclaves, air samplers, light microscope, biosafety cabinets and water systems.
Strong documentation practices and GMP compliance.
MS Office proficiency: Word, Excel, Access, Outlook.

Responsibilities

Prepare, review, and approve SOPs, test methods, protocols, reports, CAPA-related documents.
Provide cGMP training, technical support, and train analysts in microbiology practices.
Lead investigations, deviations, CAPA implementation, and SOP reviews.
Provide QC data and information to regulatory personnel during inspections.
Support process improvements and expansion initiatives.
Develop procedural guidelines within Microbiology with QA.
Participate in cleaning validation, environmental monitoring, and related testing programs.
Monitor FDA publications and industry guidelines to inform best practices.
Collaborate with management to set testing priorities and equipment needs.
Perform other related duties as required.