Job Details

Principal Scientist, Drug Product

Principal Scientist, Drug Product

Apply locations: Hopewell | Time type: Full time | Posted on: Posted 23 Days Ago | Job requisition id: R27163

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. During this transition period, both "BeiGene" and "BeOne" may be used to describe the company. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

General Description:

This role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing Technology Transfer and support. Based in New Jersey (Hopewell), this role will lead the Hopewell drug product MST function to support technology transfer, validation, continued process verification, investigations, change management, and site startup of Hopewell internal drug product manufacturing activities. Reporting to the MST leadership, this role is responsible for managing technical operations supporting both clinical and commercial manufacturing activities.

Leadership:

• Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy, and documentation are in place.
• Collaborate with DP/SC/QC/QA to develop testing strategies for DP raw materials and in-process samples.
• Author and maintain process control strategy documents throughout the lifecycle of a program and maintain process risk assessment documents.
• Author PPQ protocols and reports. Oversee execution of PPQ and related activities.
• Support engineering teams on equipment selection, qualification, and start-up activities.
• Monitor and trend process performance, including input and output parameters.
• Responsible for technical transfer, validation, investigation, and support of aseptic manufacturing operations in Hopewell and CMOs. Collaborate with Drug Product Operations to establish robust manufacturing performance.
• Collaborate with Global DP MST and Technical Development to enable new DP filling capabilities at Hopewell.
• Provide technical support for Drug Product Operations, including operational metrics, budgeting, and planning.
• Establish a data-driven culture, maintaining alignment with global manufacturing sites through shared knowledge, data, issues, and solutions.
• Partner with GZ Technical Development to transfer and validate HPW DP processes, including parenteral vials and lyophilized products. Investigate and resolve complex manufacturing issues at CMOs.
• Manage global change processes, ensuring stakeholder alignment. Assist in regulatory filings and health authority inspections to maintain product pipelines and portfolios.

Essential Functions:

• Lead technology transfer for cGMP manufacturing of drug product fill/finish.
• Ensure effective communication, risk assessment, timeline management, issue resolution, and documentation across teams.
• Execute scale-down models of manufacturing processes, maintaining good laboratory practices.
• Author and update process control strategy and risk assessment documents.
• Oversee PPQ protocols and their execution.
• Support engineering activities related to equipment qualification and start-up.
• Trend process performance data, investigate deviations, and implement CAPA.
• Identify opportunities for system and practice improvements.
• Collaborate with Process Development, Process Sciences, Manufacturing, Quality, and Project Management teams to facilitate successful technology transfer and project execution.

Preferred Skills/Experience:

• Facility start-up experience
• Commissioning, qualification, and validation expertise
• Process and equipment design knowledge
• Experience with risk assessments, health authority audits, and regulatory interactions
• Knowledge of OE and LEAN methodologies
• Experience with distributed control systems and automation
• Investigation and deviation assessment skills
• Familiarity with SAP, LIMS, CMMS, Veeva
• Expertise in aseptic filling operations, isolator, packaging, and inspection machines
• Experience with IQ/OQ/PQ and process engineering
• Knowledge of late-stage/market drug product transfer, process validation, and biopharmaceutical manufacturing
• Understanding of GMP and regulatory requirements
• Ability to work independently and in teams, manage multiple projects, troubleshoot complex issues, and communicate effectively

Qualifications:

• BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering, or related field
• At least 7 years of experience in biopharmaceutical DP process development or manufacturing

Physical Requirements:

• Ability to stand for long periods, reach, bend, push, pull, handle, lift up to 40 lbs, and work in varying temperatures
• Frequent movement, repetitive motions, and working with hazardous materials

Computer Skills: Proficiency in Word, Excel, PowerPoint

Travel: Periodic domestic and international travel

Global Competencies:

Our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit guide us. We foster teamwork, honesty, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking, financial excellence, and effective communication.

Salary Range: $132,200 - $177,200 annually

BeOne is committed to fair pay and equitable practices, considering individual skills, experience, education, and location. Compensation packages may include bonuses, stock options, and benefits such as health insurance, 401(k), paid time off, and wellness programs.

We are an equal opportunity employer, valuing diversity and merit in employment decisions.