Associate Director, Drug Substance Manufacturing (Hopewell, NJ)

BeOne Medicines • Pennington, NJ • 6h ago

General Description:

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.).

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