Associate Director - Permanent - Massachusetts, US
Lead the science. Shape the strategy. Drive world-class sterility assurance in a cutting-edge biotech manufacturing environment.
Proclinical is seeking a dedicated and experienced professional for the role of Associate Director in Contamination & Sterility Control.
Primary Responsibilities:
The successful candidate will focus on leading contamination control strategies and sterility assurance activities within a biotechnology manufacturing environment. This role requires a hands-on approach, frequent presence on the manufacturing floor, and collaboration across multiple departments to ensure compliance with regulatory standards and best practices in aseptic manufacturing.
Skills & Requirements:
- Degree in Microbiology, Life Sciences, Pharmacy, or a related field (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.
The Associate Director's responsibilities will be:
- Develop, implement, and maintain the Contamination Control Strategy (CCS) in alignment with regulatory guidelines such as EU Annex 1 and FDA aseptic guidance.
- Integrate CCS into isolator operations, cleanroom design, gowning practices, material flow, and aseptic processes.
- Provide sterility assurance expertise for site changes, process improvements, and operational decisions impacting contamination control.
- Oversee environmental monitoring (EM) programs, including zoning, sampling design, alert-action levels, and trending, in partnership with Quality Control (QC).
- Lead or support investigations related to sterility assurance, such as EM excursions, media fill failures, and bioburden issues, ensuring robust root cause analysis and corrective actions.
- Present contamination control risks and trends to site leadership and drive data-based decision-making.
- Author and manage sterility assurance-related documentation, including change controls, risk assessments, CAPAs, and deviations.
- Serve as a subject matter expert during audits and inspections, providing expertise on CCS, EM, aseptic execution, and related topics.
- Conduct routine floor audits to assess aseptic behaviors, gowning, and contamination control practices.
- Coach and train personnel to reinforce sterile execution culture and expectations.
- Support aseptic training, qualification, and certification programs.
- Collaborate with cross-functional teams to proactively manage sterility assurance risks.
- Ensure compliance with GMP regulations, internal policies, and Good Documentation Practices.