Sterility Assurance Director | Aseptic Quality Leadership

BeOne Medicines Ltd.

Pennington (NJ)

On-site

USD 180,000 - 240,000

Full time

14 days+

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Job summary

BeOne Medicines Ltd. seeks an Associate Director to lead the sterility quality assurance program at the Hopewell, NJ site, driving contamination control, aseptic processing oversight, and regulatory readiness.

The role requires 8+ years in microbiology/quality assurance with advanced knowledge of sterile manufacturing; strong leadership, strategic thinking, and cross-functional collaboration are essential for success.

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 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.

Responsibilities

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.