Director, Small Molecule Manufacturing & Tech Transfer

BeiGene, Ltd.; Hopewell (VA); On-site; USD 175,000 - 235,000; Full time

Job summary

BeOne Medicines Ltd. seeks an experienced Manufacturing Science and Technology SME for Oral Solid Dose at our Hopewell, NJ site.

The role leads technology transfer, lifecycle validation, and regulatory filing support, working with Process Development, Manufacturing, QA and Regulatory Affairs to ensure successful commercial manufacturing. The position requires 10+ years in pharma, a Bachelor’s degree (Master’s preferred), and strong GMP knowledge.

Qualifications

• Bachelor's degree in pharmaceutical sciences or related field required.
• 10+ years of pharmaceutical industry experience; leadership experience desirable.
• Six sigma green/black belt preferred; strong process improvement background.

Responsibilities

• Serve as site SME for Oral Solid Dose manufacturing and lead tech transfer.
• Oversight of lifecycle validation and process characterization.
• Lead regulatory filing documentation and inspections support.
• Collaborate across Manufacturing Operations, QA/QC, Facilities/Engineering, and Regulatory Affairs.
• Manage multiple projects in a fast-paced environment.
• Hire, train and develop technical team for start-up and commercial manufacturing.
• Ensure GMP compliance and effective problem solving of deviations.

Skills

OSD manufacturing

Technical writing

Regulatory experience

Root cause analysis

Team leadership

Lifecycle validation

GMP knowledge

Cross-functional collaboration

Data analysis

Communication skills

Education

Bachelor's degree (pharma)

Master's degree (related field)

Tools

MS Office

JMP

Minitab

Regulatory filings tools

Job description

BeOne Medicines Ltd. seeks an experienced Manufacturing Science and Technology SME for Oral Solid Dose at our Hopewell, NJ site.

The role leads technology transfer, lifecycle validation, and regulatory filing support, working with Process Development, Manufacturing, QA and Regulatory Affairs to ensure successful commercial manufacturing. The position requires 10+ years in pharma, a Bachelor’s degree (Master’s preferred), and strong GMP knowledge.