Associate Director, Drug Substance Manufacturing (Hopewell, NJ)

Overview BeOne continues to grow at a rapid pace with opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our interest in fighting cancer. This site leadership position reports to the General Manager (Site Head) at Hopewell, NJ, leading a team and aligning with BeOne global competencies: Patient First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence. The role requires collaboration with cross-functional teams to deliver product volumes, lead process optimizations, execute tech-transfers, and lead global health authority inspections. Responsibilities include CQV commissioning, GMP readiness, commercial operation, and delivering volumes to meet product lifecycle demand. The role focuses on leading technical implementation for large molecule manufacturing related to liquid aseptic filling and lyophilization. Responsibilities Build an organization with strong core values and behaviors into a culture that produces high quality manufacturing processes. Lead and develop a highly skilled, focused, and well-trained organization. Demonstrate excellence in behavioral competencies: Patient First, Collaborative Spirit, Bold Ingenuity, Driving Excellence. Responsible for Equipment FAT/SAT/IOQ/and commissioning while maintaining established timelines. Ensure strict adherence to all compliance requirements (quality and EHS). Maintain good communication and technical writing skills including technical reports, change controls, CAPA, and deviations. Lead Product Change Over (PCO) activities. As part of the site leadership team, define operational strategy and direction. Lead the function ensuring appropriate scientific, regulatory, and quality standards across facility design, construction, and validation, and GMP operation system establishment. Provide scientific guidance and oversight considering technical, regulatory, intellectual property, and risk assessment considerations. Education and Experience Bachelor’s Degree in a relevant field (e.g., Biotech, Biology, Chemical Engineering, Biochemistry, or Life Sciences). Master’s degree preferred. Advanced degree (Master’s, PhD) preferred for competitive candidates though not mandatory with sufficient experience. Minimum 8 years of experience in large molecule manufacturing with a focus on Cell Culture processing. Demonstrated success in single-use manufacturing processes. Minimum 6 years in a leadership role. Deep understanding and experience in a cGMP environment. Proven experience with cGMP, FDA/EMA regulations, and successful regulatory inspections (e.g., pre-approval inspections, PAI). Deep understanding of quality system requirements (CAPA/DEV/CC, etc.). Lean Six Sigma/Operational excellence background with a proven continuous improvement track record. Computer skills: familiarity with SCADA, DCS, SAP, Word, Excel, PowerPoint, etc. Travel Minimal – approx. 10% travel (Global). Global Competencies When we exhibit our values, we aim to get more affordable medicines to more patients. Competencies include: fostering teamwork, giving and receiving honest feedback, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, embracing change, results orientation, analytical thinking/data analysis, financial excellence, and clear communication. Salary and Benefits Salary Range: $139,200.00 – $189,200.00 annually. BeOne is committed to fair and equitable compensation practices. Packages vary by location and are based on factors including skills, experience, certifications, education, and work location. The recruiter can share location-specific details during the hiring process. The listed range reflects base salary or hourly range only. Eligible employees may participate in annual bonuses or incentive plans. Employees may have opportunities for discretionary equity awards and participation in the Employee Stock Purchase Plan. Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs. Equal Opportunity BeOne is proud to be an equal opportunity employer. We do not discriminate on basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis protected by law. Employment decisions are based on qualifications, merit, and business need. Reasonable accommodation requests in the application process may be directed to View email address on click.appcast.io, as permitted by applicable laws. About BeOne BeOne is a global oncology company discovering and developing affordable treatments to fight cancer worldwide. Our growing global team exceeds 11,000 colleagues across six continents. Learn more at and follow us on LinkedIn, X, Facebook, and Instagram. For China Mainland job opportunities, see the provided China Mainland Job Posting. #J-18808-Ljbffr