Contamination & Sterility Control, Associate Director

Proclinical Staffing; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Proclinical Staffing seeks an Associate Director in Contamination & Sterility Control for a cutting-edge biotech manufacturing site in Massachusetts. The role focuses on leading contamination control strategies, ensuring aseptic execution, and coordinating across departments to meet regulatory standards.

The ideal candidate will have deep expertise in sterility assurance, environmental monitoring, and regulatory compliance, with a track record of leading investigations and risk-based decision

Qualifications

• 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.

Responsibilities

• 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.

Skills

Sterility assurance

Aseptic processing

Contamination control

Isolator manufacturing

Environmental monitoring

Media fills

Aseptic filling

Regulatory inspections

Root cause investigations

Quality documentation

Risk assessment

Data-driven decisions

Cross-functional leadership

Communication

Education

Degree in Microbiology, Life Sciences, Pharmacy, or related field

Job description

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.