Global Analytical Director, Lifecycle & Compliance

BeiGene, Ltd.; Northern (KY); Hybrid; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness programs

Job summary

BeOne Medicines Ltd. seeks an Analytical Technical Lead to serve as the global PoC for analytical topics across major markets and to drive lifecycle management for DS/DP and critical reagents.

You will lead investigations, CAPA, and method improvements while ensuring compliance with GMP and regulatory expectations. You will also own global specifications, stability programs, and submission-ready documentation, coordinating with QC sites, CMOs, and Regulatory CMC teams to sustain robust

Qualifications

• Bachelor’s degree and 10+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience required.
• Master’s degree and 7+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience preferred.
• Doctoral Degree and 5+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience desired.
• Strong GMP QC and analytical sciences for small molecule methods (HPLC/UPLC, GC, dissolution, solvents, impurities).
• Knowledge of method validation/verification, stability trends, statistics, and data integrity.

Responsibilities

• Act as the global PoC for analytical topics for assigned products across major markets.
• Lead analytical lifecycle management with root-cause analysis and CAPA.
• Own global specifications governance and stability program ownership.
• Provide analytical SME leadership for RoW regulatory submissions and post-approval variations.
• Govern external QC networks, support audits/inspections, and manage lab capacity planning.
• Travel up to 20% to support global operations.

Skills

Analytical leadership

GMP QC

HPLC/UPLC

Regulatory submissions

Project management

Cross-functional collaboration

Education

Bachelor's degree in Biopharmaceuticals

Master's degree in Biopharmaceuticals

Doctoral degree in Biopharmaceuticals

Job description

BeOne Medicines Ltd. seeks an Analytical Technical Lead to serve as the global PoC for analytical topics across major markets and to drive lifecycle management for DS/DP and critical reagents.

You will lead investigations, CAPA, and method improvements while ensuring compliance with GMP and regulatory expectations. You will also own global specifications, stability programs, and submission-ready documentation, coordinating with QC sites, CMOs, and Regulatory CMC teams to sustain robust