Contamination & Sterility Control, Associate Director

Primary Responsibilities

• Lead contamination control strategies and sterility assurance activities.
• Frequent presence on the manufacturing floor to collaborate across multiple departments.
• Ensure compliance with regulatory standards and best practices in aseptic manufacturing.

Skills & Requirements

• Microbiology, Life Sciences, Pharmacy, or related field degree (advanced degrees preferred).
• Expertise in sterility assurance, aseptic processing, and contamination control in pharmaceutical or biotechnology manufacturing.
• Strong knowledge of isolator-based manufacturing, EM programs, media fills, and aseptic filling operations.
• Experience with regulatory inspections, root cause investigations, and quality system documentation.
• Proficiency in risk assessment facilitation and data-driven decision-making.
• Ability to work collaboratively across departments and lead initiatives in a fast-paced environment.
• Strong communication and leadership skills to coach and mentor teams effectively.