Associate Director, Drug Substance Manufacturing (Hopewell, NJ)

Job Title

This position reports directly to the General Manager (Site Head) and is a site leadership position at Hopewell, NJ.

This role leads a team and requires robust demonstration of key leadership behaviors aligned with BeOne global competencies (Patient First, Collaborative Spirit, Bold Ingenuity and Driving Excellence). Expectations of this role are to work collaboratively with other functional teams to deliver required product volumes, lead process optimizations, execute tech-transfers, and lead global health authority inspections. Responsibilities also include CQV commissioning, GMP readiness, commercial operation and delivery of required volumes to meet product lifecycle demand.

This role will focus on leading technical implementation of cutting-edge 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.
• Leading and building a highly skilled, focused, and well-trained organization.
• Demonstrated excellence in behavioral competencies (Patient First, Collaborative Spirit, Bold Ingenuity, Driving Excellence).
• Responsible for Equipment FAT/SAT/IOQ/ and commissioning while maintaining established timelines.
• Strict adherence to all compliance requirements (both quality and EHS).
• Must have good communication and technical writing skills including technical reports, change controls, CAPA, and deviations.
• Leads Product Change Over (PCO) activities.
• As a part of the site leadership team to define operational strategy and direction.
• Lead the function ensuring that appropriate scientific, regulatory, and quality standards are followed across manufacturing facility design, construction, and validation, GMP operation system establishment.
• Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.

Education and Experience Required

• Bachelor's Degree in relevant field (e.g., Biotech, Biology, Chem Eng, Biochemistry or Life Sciences). Master's degree preferred.
• Preferred: Advanced degree (Master's, PhD) for competitive candidates though not mandatory with sufficient experience.
• Minimum of 8 years of experience in large molecule manufacturing with a focus on Cell Culture processing.
• Demonstrated success in single-use manufacturing processes.
• Minimum of 6 years in a leadership role.
• Deep understanding and experience working in a cGMP environment.
• Proven experience with cGMP, FDA/EMA regulations, and successful regulatory inspections (e.g., pre-approval inspections, PAI).
• Deep understanding of all quality system requirements (CAPA/DEV/CC, etc.).
• Lean Six Sigma/Operational excellence background with proven continuous improvement track record.

Computer Skills: Familiarity with computer-based systems: (SCADA, DCS, SAP, Word, Excel, PowerPoint, etc.).

Travel: Minimal 10%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $139,200.00 - $189,200.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact View email address on click.appcast.io.