Scientist, Manufacturing Science and Technology, Cell Culture; Hopewell, NJ

Scientist, Manufacturing Science and Technology, Cell Culture (Hopewell, NJ)

BeOne Medicines is growing rapidly and seeks an experienced Scientist to lead Cell Culture operations in our Hopewell, NJ manufacturing site. The role includes media preparation, inoculum, seed/production cultivation and harvest processes and supports process improvements, troubleshooting, compliance, tech transfer and continuous process verification. The position reports directly to the Associate Director, MST Cell Culture.

• Execute laboratory experiments and maintain support laboratory activities.
• Author study protocols, reports and documentation supporting deviations, regulatory activities and process validation plans.
• Perform tech transfer activities including facility gap analysis, risk assessment and development of technical transfer plans, process descriptions, control strategies and campaign summary reports.
• Provide technical support as SME for implementation of cell culture processes and serve as Person‑In‑Plant during critical manufacturing steps.
• Analyze manufacturing data, perform continued process verification (CPV) and process monitoring during campaigns.
• Communicate effectively with cross‑functional teams and stakeholders.
• Perform additional assignments as determined by the manager.

• BA/BS in science, biochemistry, biotechnology, biology, chemical engineering or related discipline with 2+ years of Life Science/Biotechnology experience.
• Knowledge of Mab facilities, process design/development and biopharmaceutical equipment qualification and validation activities.
• Cell culture expertise including inoculum processes, bioreactor systems, harvest processes and analytical equipment.
• Strong data analysis skills and experience with DOE, statistical software (JMP, SAP, or equivalent).
• Experience with tech transfer to clinical/commercial manufacturing facilities and authoring of study protocols/reports.
• Good understanding of GMP requirements and experience working in a cell culture laboratory or equivalent.
• Project management skills, regulatory knowledge (FDA, EMA, ICH, PDA) and effective communication in a multidisciplinary environment.
• Proficiency in Microsoft Office and JMP or SAP.

• MS Office (Outlook, Word, Excel, PowerPoint).
• JMP or equivalent; SAP or equivalent.

• Reach above shoulder level, bend, stoop, push, pull and handle frequently.
• Work 40 hours per week with overtime as needed; comfortable working in varying temperatures.
• Use gowns in manufacturing areas when required and work with hazardous materials.

Some travel may occur as a result of duties assigned to the role, up to 20%.

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. For reasonable accommodation for protected individuals, contact