Director, Quality Analytical Technical Lead, Small Molecule

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

About the role

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.

Responsibilities

• Act as the global point of contact for all analytical-related matters for assigned products, ensuring 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.
• 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.
• 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.
• 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.
• 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.

Requirements

• Bachelor’s degree and 10+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility required.
• Master’s degree and 7+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility preferred.
• Doctoral Degree and 5+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility desired.
• Strong PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).
• 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.

Skills

• 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.
• Up to 20% global travel.

Global Competencies

• 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

Pay

Salary range: $168,000.00 - $228,000.00 annually. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location. 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 employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and the Employee Stock Purchase Plan.

Benefits

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