Global Analytical Director, Lifecycle Leadership

BeiGene, Ltd.; United States; Remote; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. in the United States seeks an Analytical Technical Lead to own analytical lifecycle management for assigned products across major markets, ensuring GMP compliance and robust control strategies.

The role leads global governance for specifications, stability, and method validation, partners with Regulatory CMC, and oversees external QC labs and CMOs, with up to 20% travel. This senior leadership position requires strategic thinking and cross-functional collaboration.

Qualifications

• Bachelor’s degree with 10+ years biopharma commercial lifecycle experience.
• Strong leadership in GMP QC and analytical sciences.
• Experience with validation/verification, stability trends, data integrity.

Responsibilities

• Global analytical PoC for approved products; govern analytics across DS/DP and labs/CMOs.
• Lead analytical lifecycle management with investigations and CAPA; drive changes.
• Own global process areas: specifications, stability, retest/shelf life governance.
• Provide analytical SME leadership for RoW regulatory submissions and post-approval variations.
• Govern external QC networks and support inspections; manage lab capacity and escalations.

Skills

Leadership in GMP QC

Analytical sciences

HPLC/UPLC/GC methods

Dissolution & impurities control

Method validation/verification

Education

Bachelor’s degree

Master’s degree preferred

Doctoral degree desired

Job description

BeOne Medicines Ltd. in the United States seeks an Analytical Technical Lead to own analytical lifecycle management for assigned products across major markets, ensuring GMP compliance and robust control strategies.

The role leads global governance for specifications, stability, and method validation, partners with Regulatory CMC, and oversees external QC labs and CMOs, with up to 20% travel. This senior leadership position requires strategic thinking and cross-functional collaboration.