Associate Director of Sterility Assurance & Microbial Controls

EPM Scientific; Philadelphia (Philadelphia County); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading pharmaceutical company is seeking an Associate Director of Sterility Assurance & Microbial Controls to lead the establishment of robust sterility and microbial governance programs at a new manufacturing facility in Pennsylvania. You will be responsible for overseeing aseptic operations, contamination control strategies, and environmental monitoring, ensuring compliance with FDA and EU regulations. The ideal candidate will possess significant experience in sterile manufacturing and strong leadership skills for team development and program ownership.

Qualifications

• 8-12+ years of progressive experience in sterile/aseptic pharmaceutical manufacturing.
• Strong knowledge of FDA, EMA, EU Annex 1 regulations.
• Experience supporting new facility startups or major capital projects.

Responsibilities

• Lead a team for sterility assurance and contamination control.
• Develop and oversee microbial risk assessments.
• Partner with operations to ensure adherence to cleaning and disinfection standards.

Skills

Contamination control

Aseptic techniques

Microbial risk management

Leadership

Education

Bachelor's degree in Microbiology, Biology, Life Sciences, Engineering, or equivalent

Tools

Environmental Monitoring (EM)

Rapid microbial methods

Job description

A leading pharmaceutical company is seeking an Associate Director of Sterility Assurance & Microbial Controls to lead the establishment of robust sterility and microbial governance programs at a new manufacturing facility in Pennsylvania. You will be responsible for overseeing aseptic operations, contamination control strategies, and environmental monitoring, ensuring compliance with FDA and EU regulations. The ideal candidate will possess significant experience in sterile manufacturing and strong leadership skills for team development and program ownership.