Global Analytical Director

BeOne Medicines

United States

On-site

USD 168,000 - 228,000

Full time

14 days+
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Benefits offered by this job

Medical, Dental, Vision
Equity awards
Employee Stock Purchase Plan
Bonus eligible

Job summary

BeOne Medicines seeks an Analytical Technical Lead to own analytical lifecycle management for commercial products across US, EU, China, Australia and Canada. You will provide governance for DS/DP analyses, drive method validation, stability, and regulatory readiness with internal QC sites, external labs, and CMOs.

The role requires 10+ years in biopharma, advanced degrees, and proven leadership in GMP QC; travel up to 20%.

Qualifications

  • Experience in GMP QC and analytical sciences for small molecules.
  • Strong knowledge of method validation/verification and stability trends.
  • Experience with data integrity and regulatory submissions.

Responsibilities

  • Act as global analytical PoC for commercial products and lead investigations.
  • Oversee analytical control strategy, specification governance, and lifecycle management.
  • Provide regulatory-facing analytical documentation and support RoW filings.

Skills

GMP QC leadership
Analytical sciences knowledge
Method validation/verification
Stability trends & statistics
Data integrity

Education

Bachelor’s degree and 10+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility
Master’s degree and 7+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility
Doctoral Degree and 5+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility

Tools

HPLC/UPLC
GC
Dissolution
Residual solvents
Elemental impurities
Genotox impurities

Job description

BeOne Medicines seeks an Analytical Technical Lead to own analytical lifecycle management for commercial products across US, EU, China, Australia and Canada. You will provide governance for DS/DP analyses, drive method validation, stability, and regulatory readiness with internal QC sites, external labs, and CMOs.

The role requires 10+ years in biopharma, advanced degrees, and proven leadership in GMP QC; travel up to 20%.

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