Senior Engineer Drug Substance Manufacturing

BeiGene - Hopewell, NJ

Full-time - Mid Level

Hopewell, NJ

Chemical Manufacturing

About the position

The Senior Engineer role at BeiGene focuses on providing technical expertise in the production of monoclonal antibodies (mAb) within a commercial biopharmaceutical facility. The primary objective is to support the start-up and licensure of a new drug substance production facility in Hopewell, NJ, ensuring robust and compliant cGMP operations. This role involves collaborating with cross-functional teams to optimize processes, troubleshoot issues, and support regulatory inspections.

Responsibilities

• Support and execute the design, start-up, validation, and licensure of BeiGene's first biopharmaceutical facility in the United States.
• Enable reliable and compliant execution of DS and DP cGMP operations, including deviation evaluation and process monitoring.
• Drive process optimization and facilitate technology transfer of new products to the facility.
• Identify and implement improvement opportunities that align with BeiGene's vision and mission.
• Conduct statistical analysis, modeling, testing, and system optimization.
• Develop and maintain positive relationships with internal and external stakeholders throughout facility and equipment design phases.
• Review CMC sections for accuracy in submissions.
• Communicate effectively with team members and stakeholders.
• Supervise and manage contract manufacturers as required.

Requirements

• BS or MS in pharmaceutical Science, Engineering, or advanced scientific discipline.
• Minimum of 5+ years of process engineering experience in a commercial biopharmaceutical facility.
• Knowledge of process and equipment related to cell culture operations from vial thaw through bulk filtration.
• Experience with vendor management, including selection and qualification.
• Technical Transfer experience, including equipment qualification and process validation.
• Experience working on project teams to resolve complex production issues.
• Familiarity with deviation and change management systems.
• Strong interpersonal, teamwork, self-management, and organizational skills.
• Effective oral and written communication skills for a multi-disciplinary work environment.
• Working knowledge of relevant biopharma FDA regulations (FDA, EMA, ICH, PDA).
• Broad knowledge of drug development, CMC, preclinical and clinical requirements.
• Familiarity with Microsoft Office, including Project and Visio.

Nice-to-haves

• Experience with automated control systems.
• Hands-on experience in the design and troubleshooting of systems used in drug substance production.