Director, Small Molecule Manufacturing Science & Tech

BeOne Medicines; Hopewell (NJ); On-site; USD 175,000 - 235,000; Full time

Benefits offered by this job

401(k)

Medical, Dental, Vision

Paid Time Off

Job summary

BeOne Medicines seeks an experienced Manufacturing Science and Technology expert to serve as the site SME for Oral Solid Dose manufacturing at the Hopewell, NJ site. You will lead technology transfer, lifecycle validation, and provide technical leadership for startup activities and equipment selection.

The role requires strong collaboration with Process Development, Manufacturing, QA, and Regulatory Affairs, with significant regulatory filing and inspection experience.

Qualifications

• 10+ years of pharmaceutical industry experience.
• Experience with technology transfer and lifecycle validation.
• Strong technical writing for transfer plans, validation reports, and regulatory submissions.
• Regulatory health authority inspection experience.

Responsibilities

• Lead technology transfer for Oral Solid Dose manufacturing.
• Oversee lifecycle validation, process characterization and continued process verification.
• Provide technical leadership for facility design, equipment selection, and startup activities.
• Collaborate with Process Development, Process Sciences, Manufacturing, Quality, and CMC project management.
• Support regulatory submissions and regulatory filing documents.

Skills

Small Molecule

OSD manufacturing

Technology transfer

Regulatory writing

CAPA / deviations

Cross-functional collaboration

Data analysis

Technical leadership

Education

Bachelor’s degree in pharmaceutical sciences

Master’s degree preferred

Tools

JMP

Minitab

MS Office

Job description

BeOne Medicines seeks an experienced Manufacturing Science and Technology expert to serve as the site SME for Oral Solid Dose manufacturing at the Hopewell, NJ site. You will lead technology transfer, lifecycle validation, and provide technical leadership for startup activities and equipment selection.

The role requires strong collaboration with Process Development, Manufacturing, QA, and Regulatory Affairs, with significant regulatory filing and inspection experience.