Sr Manager Quality, Contamination Control Strategy Lead

Simtra BioPharma Solutions

2 days ago

3.1 on Glassdoor

Bloomington, Indiana, United States

Onsite

Full Time

Senior

0 applicants

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About this role

The Sr Manager Quality, Contamination Control Strategy Lead ensures contamination control strategy compliance and aseptic practices at a sterile injectable manufacturing facility. The role involves leading contamination control initiatives, microbiological oversight, and aseptic assurance across the site.

Skills

Qualifications

Bachelors degree in Microbiology (preferred), Biology, Pharmacy, or related scienceMasters degree or higher in Microbiology or Pharmaceutical Sciences is preferredMinimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA rolesDemonstrated leadership or cross-functional team experience in aseptic processing environmentsProven track record of successful regulatory inspection participation (FDA, EMA, or equivalent) as SME for contamination control topics

About Simtra BioPharma Solutions

simtra.com

Simtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) focused on sterile injectable products. They offer end-to-end services — from formulation and analytical development through aseptic fill/finish, packaging, quality and regulatory support — to advance programs from clinical stages to commercial supply. Simtra emphasizes flexible product delivery options and a compliance-driven approach to meet biopharma partners’ timelines and manufacturing requirements.