Associate Director, Sterility Assurance

beigene; Hopewell (VA); On-site; USD 150,000 - 190,000; Full time

Job summary

BeOne seeks a senior Sterility Assurance Leader for the Hopewell, NJ site to steer the site sterility assurance and contamination control programs in alignment with cGMP and FDA expectations. The role involves technical oversight of aseptic processing, environmental monitoring, cleanroom controls, cleaning, sterilization, and validation lifecycles.

The incumbent will lead investigations of sterility and aseptic events, drive CAPAs, monitor trends, and collaborate across functions to ensure

Qualifications

• 8+ years in microbiology or biological quality assurance in FDA-regulated pharma/biotech.
• Experience leading regulatory inspections and ownership of a Contamination Control Strategy.
• Advanced knowledge of aseptic processing, environmental monitoring, and CAPA management.
• Strong leadership, communication, analytical and project-management skills.

Responsibilities

• Lead site sterility assurance and contamination control programs.
• Own Contamination Control Strategy including risk assessment and CAPAs.
• Provide technical oversight for aseptic processing, environmental monitoring, cleanroom controls, sterile filtration, and validation lifecycles.
• Lead or support aseptic process simulations, gowning certification, cleanroom qualification, and validation lifecycle activities.
• Direct investigations of sterility, microbiological, environmental events; ensure robust root-cause analysis and CAPAs.
• Assess contamination risks and define mitigation and monitoring strategies.
• Review trends/KPIs, drive continuous improvement, and maintain inspection readiness.
• Serve as SME during regulatory inspections, audits, technology transfers, process validation, and manufacturing campaigns.
• Develop, review, and approve policies, procedures, protocols, reports, changes controls, deviations, CAPAs, and risk assessments.
• Provide technical leadership, coaching, and mentorship across the sterility assurance program.

Skills

Sterility assurance

Regulatory inspections leadership

Quality risk management

Project management

Cross-functional leadership

Communication skills

Education

Bachelor of Science in related field

Master's degree

Tools

Microsoft Office Suite

Job description

General Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The 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 (