Associate Director, Sterility Assurance

BeOne Medicines; Pennington (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

BeOne Medicines seeks an Associate Director of Sterility Quality Assurance at its Hopewell, NJ site to lead the sterility assurance program and ensure compliant sterile manufacturing operations.

The role serves as the site SME for aseptic processing, environmental monitoring, and contamination control, partnering with Manufacturing, QC Microbiology, Engineering, Validation, and Regulatory Affairs to protect product quality and patient safety.

Qualifications

• Bachelor of Science degree and 8+ years of relevant experience in microbiology or quality assurance in an FDA-regulated setting.
• Master’s degree and 6+ years of related scientific experience preferred.
• Experience in Regulatory inspection leadership and contamination control ownership.
• Advanced knowledge of aseptic processing, environmental monitoring, and validation.
• Strong technical judgment, leadership, communication, analytical, and project-management skills.

Responsibilities

• Lead and continuously improve the site sterility assurance and contamination control programs in alignment with cGMP, FDA requirements, EU GMP Annex 1, and global standards.
• Own or co-own the Contamination Control Strategy, including risk assessment, governance, performance monitoring, periodic review, and remediation of identified gaps.
• Provide technical oversight for aseptic processing, environmental controls, cleanroom operations, sterilization, and sterile filtration.
• Lead aseptic process simulations, operator qualification, gowning certification, and validation lifecycle activities.
• Direct investigations of sterility and environmental events with robust root-cause analysis and CAPAs.
• Assess contamination risks and define mitigation and monitoring strategies.
• Review trends and KPIs to drive continuous improvement and inspection readiness.
• Serve as SME during regulatory inspections, audits, transfers, and manufacturing campaigns.
• Develop, review, and approve policies, procedures, and risk assessments related to sterile manufacturing.

Skills

Leadership

Communication

Project management

Analytical thinking

Strategic thinking

Customer focus

Problem-solving

Cross-functional collaboration

Education

Bachelor of Science degree

Master’s degree (preferred)

Tools

Microsoft Office

Job description

General Description:

The Associate Director, Sterility Quality Assurance provides strategic and technical leadership for the site sterility assurance program, ensuring sterile manufacturing operations remain compliant, scientifically sound, and in a sustained state of control. Serving as the site subject matter expert for aseptic processing and contamination control, this role leads implementation and lifecycle management of the Contamination Control Strategy and partners with Manufacturing, Quality Control Microbiology, Engineering, Validation, MSAT, and Regulatory Affairs to protect product quality and patient safety. This position is located at the Hopewell, NJ Site.

Essential Functions of the job:

• Lead and continuously improve the site sterility assurance and contamination control programs in alignment with cGMP, FDA requirements, EU GMP Annex 1, and applicable global standards.




• Own or co-own the Contamination Control Strategy, including risk assessment, governance, performance monitoring, periodic review, and remediation of identified gaps.




• Provide technical oversight for aseptic processing, environmental and personnel monitoring, cleanroom controls, cleaning and disinfection, critical utilities, sterilization and depyrogenation, sterile filtration, isolator systems, and container closure integrity.




• Lead or support aseptic process simulations/media fills, operator qualification and requalification, gowning certification, cleanroom qualification, and validation lifecycle activities.




• Direct investigations of sterility, microbiological, environmental, and aseptic-process events; ensure robust root cause analysis, scientifically justified impact assessments, and effective CAPAs.




• Assess contamination risks associated with facilities, equipment, utilities, processes, materials, suppliers, and changes, and define appropriate mitigation and monitoring strategies.




• Review trends and key performance indicators to identify adverse signals, drive continuous improvement, and maintain inspection readiness.




• Serve as the sterility assurance subject matter expert during regulatory inspections, customer audits, facility design reviews, technology transfers, process validation, and commercial manufacturing campaigns.




• Develop, review, and approve policies, procedures, protocols, reports, change controls, deviations, CAPAs, and risk assessments related to sterile manufacturing.




• Provides technical leadership, coaching, and mentorship across the sterility assurance program. The position currently has no direct reports but may assume formal people-management responsibilities as the site organization grows.

Qualifications:

• Bachelor of Science degree and 8+ years of relevant experience in microbiology, biological quality assurance, with advanced knowledge of large molecule sterile manufacturing in an FDA regulated biotechnology or pharmaceutical company with progressively responsible experience is required.




• Master’s degree and 6+ years of related scientific experience preferred.




• Experience in Regulatory inspection leadership, commercial sterile biologics experience, and direct ownership of a Contamination Control Strategy.




• Advanced knowledge of aseptic processing, microbiological controls, contamination control, environmental monitoring, validation, deviation and CAPA management, quality risk management, and global regulatory expectations.




• Strong technical judgment, inspection experience, cross-functional influence, people leadership, communication, analytical, and project-management skills are required.




• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.




• Working knowledge of cGMPs: 21 CFR parts 201 & 211, Annex 1, knowledge of 21CFR600 – Biologics desirable.




• Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, manufactured under and IND or IMP). Knowledge of commercial BLA products.




• Strong personal leadership skills and experience, ability to lead small teams.




• Good communicator (written and verbal) and strategic thinker, highly customer focused.




• Strong analytical and problem-solving ability.




• Strong project management skills.




• Hands-on approach, with a ‘can do’ attitude.




• Ability to prioritize, demonstrating good time management skills.




• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.




• Self-motivated, with the ability to work proactively using own initiative.




• Committed to learning and development.



• Highly Desirable: Strong IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook).

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).




• Ability to work on a computer for extended periods of time

Other Qualifications:

• Must be able to work in the US without corporate sponsorship.

Travel:

• Ability to travel approximately 10%; Requires a valid passport.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.