About the role
We are seeking an experienced leader to drive sterility assurance and contamination control strategy across a regulated sterile manufacturing environment. This is a remote opportunity at the senior management/associate director-level role with no direct reports, requiring the ability to influence cross-functional teams through technical expertise, sound judgment, and strong stakeholder engagement.
Key Responsibilities
- Lead the development, implementation, and continuous improvement of the site's Contamination Control Strategy (CCS).
- Design and enhance environmental monitoring (EM) programs and contamination control initiatives across sterile manufacturing operations.
- Provide strategic technical leadership for aseptic processing, sterilization, and validation activities.
- Evaluate and lead investigations into contamination events across fill/finish operations as well as upstream manufacturing, including bioreactors and fermenters.
- Serve as the subject matter expert during inspections, audits, and complex technical discussions, promoting science-based, risk-focused decision making.
- Ability to travel on-site to Des Moines, Iowa region up to 50%.
Qualifications
- Bachelor's degree in Microbiology, Biology, or a related scientific discipline; advanced degree preferred.
- 15+ years of experience in sterile manufacturing, biotechnology, pharmaceuticals, vaccines, or another highly regulated environment.
- Demonstrated success establishing contamination control strategies and implementing environmental monitoring programs.
- Deep understanding of aseptic processing, sterile barriers, contamination control, and microbial risk throughout the manufacturing process.
- Experience supporting investigations involving sterile manufacturing, bioreactors, fermenters, and aseptic operations.
- Strong knowledge of current GMP requirements and contamination control best practices.
If this sounds interesting, please apply or share your resume to suhaillah.haqq@jcwgroup.com and let's find a time to chat!
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