Sr. Scientist, Drug Product, MST

General Description:

• This role in Manufacturing Science and Technology (MST) provides technical support for BeOne’s large molecule Drug Product manufacturing operations, with emphasis on lyophilization, liquid drug product processing, aseptic filling, visual inspection, technology transfer, process validation, continued process verification, continuous improvement, and quality investigations.

Essential Functions of the Job:

• Support technology transfer and lifecycle management for cGMP drug product fill/finish operations, including liquid formulation/filling and lyophilization.

• Provide on-floor and technical support to Drug Product Operations for aseptic processing, GMP practices, process troubleshooting, and manufacturing readiness.

• Author and maintain process related documents, process risk assessments, and technical documentation throughout the product lifecycle.

• Monitor, trend, and analyze process performance data to support continued process verification and identify improvement opportunities.Support qualification, process engineering, and validation activities, including IQ/OQ/PQ, PPQ, CPV, and related protocols and reports.

• Support implementation and maintenance of key drug product controls, including PUPSIT, CCIT, sterile filtration, container closure, and aseptic process controls.

• Develop and maintain Bills of Material (BOM), material specifications, and manufacturing support documentation as needed.

• Lead or support investigations for deviations and process-related events, including root cause analysis, technical impact assessment, and CAPA implementation.

• Collaborate with Manufacturing, Quality, Engineering, Validation, MSAT/MST, Supply Chain, and Document Management to support compliant and reliable operations.

• Assist in regulatory filings, audits, and Health Authority inspections related to Hopewell drug product manufacturing operations.

Supervisory Responsibilities:

• Individual Contributor (no direct reports)

• May provide technical guidance, coaching, and review support to junior staff or cross-functional team members during manufacturing support, investigations, validation, and documentation activities.

• Collaborate cross-functionally with Manufacturing, Facilities & Engineering, Validation, Quality Control/Assurance, Supply Chain, and Document Management.

Education:

• Bachelor’s degree and 4+ years of pharmaceutical Drug Product experience required

• Master’s degree and 2+ years of Drug Product experience preferred

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Experience with GMP systems for document management, deviations, CAPA, change control, training, and batch record support.

• Ability to analyze manufacturing and process performance data using Excel and statistical software such as JMP or Minitab preferred.

• Experience with SAP, Veeva, electronic batch records, or other manufacturing/quality systems preferred.

Other Qualifications:

• Technical experience in sterile drug product manufacturing, including aseptic technique, liquid drug product processing, filling, lyophilization, capping, visual inspection, and GMP documentation practices.

• Ability to apply scientific and engineering judgment to troubleshooting, investigations, risk assessments, validation, and process improvement activities.

Travel: Up to 5%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.