Director, Quality Analytical Technical Lead, Small Molecule

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 continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Analytical Technical Lead (ATL) is the single global point of contact and accountable owner for analytical lifecycle management of assigned commercial products across major markets (US, EU, China, Australia, Canada) and supports Rest of World (RoW) expansion and post-approval maintenance. At Director level, this role is responsible for making risk-based, inspection-defensible decisions on methods, specifications, stability, and analytical investigations across a distributed internal/external QC network for small molecule products. This leader ensures the analytical control strategy remains robust over the product lifecycle, drives harmonization, and enables reliable supply while meeting GMP, pharmacopeial, and regulatory expectations. The Analytical Technical Lead (ATL) may own relevant global business processes, ensure compliance and efficiency.

Essential Functions of the Job

• A. Global Analytical Point of Contact (PoC) for Approved Commercial Products

  Act as the global PoC for all analytical-related matters for assigned products, to ensure analytical readiness. Provide governance and technical leadership for analytical topics spanning drug substance (DS), drug product (DP), and critical raw materials/reagents as applicable. Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.

• B. Analytical Lifecycle Management

  Lead and approve strategy for analytical investigations and performance issues (OOS/OOT/OOE, atypical results, invalidations), ensuring scientifically sound root cause analysis and effective CAPA, including method optimization. Drive analytical change control impact assessments and execution plans, including method updates, revalidation/verification, reference standard changes, and instrument/software upgrades. Own escalation management for supply-critical analytical events; align actions with Quality, Regulatory, and Supply Chain.

• C. Global Business Process & Knowledge Owner

  Methods, Specifications, Stability, Retest/Shelf Life Serve as global business process and knowledge owner for:

  • Commercial analytical method lifecycle (validation/verification strategy, transfers, periodic review, trending, method robustness improvements)
  • Global specifications governance (release and stability), including harmonization and lifecycle updates
  • Stability program ownership (protocol strategy, commitments, pull schedules, trending, annual review narratives)
  • Retest period/shelf-life governance (extensions, commitments, labeling impacts, country-specific constraints)
  • Take over “submission-ready” documentation sources from development: analytical control strategy, method history, validation packages, specification rationale, and stability trend narratives.
  • Ensure defensible alignment between analytical control strategy and product risk profile (CQAs/CPPs), including small-molecule impurity control.
• D. Regulatory Support: RoW Filings and Post-Approval Variations

  Provide analytical SME leadership for global regulatory submissions relevant to QC: RoW filings (Module 3 analytical sections, stability commitments, method/spec alignment) Post-approval changes (variations, supplements), including comparability narratives and analytical bridging. Partner with Regulatory CMC on health authority interactions and responses related to analytical controls, stability trends, and specification justification.

• E. Partner and Network Oversight (Internal QC and External Labs/CMOs)

  Provide governance for external QC networks: align expectations, metrics, investigation quality, and issue escalation pathways (with ESQ as needed). Contribute to audits/inspections as product analytical SME; ensure inspection readiness for assigned products and analytical systems. Influence lab capacity planning and capability upgrades with a risk-based view.

Education

• 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

Computer Skills

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Other Qualifications

• Experience Demonstrated leadership in GMP QC and/or analytical sciences for: Small molecule methods (HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, genotox impurities as applicable)
• Strong working knowledge of method validation/verification, stability trends and statistical evaluation, specification lifecycle management, and data integrity.

Leadership Competencies

• Ability to lead through influence in a matrix organization; strong stakeholder management and negotiation skills.
• Strong technical writing and ability to deliver inspection-defensible narratives.
• Program and risk management mindset; ability to prioritize in supply-constrained environments.

Travel

Up to 20%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$168,000.00 - $228,000.00 annually

Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.

Please note that the listed range reflects the base salary or hourly range only.

Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in an Employee Stock Purchase Plan.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

EEO & Diversity Statements

We are proud to be an equal opportunity employer.

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

Company Overview

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit