Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a biopharmaceutical company focused on developing medicines for patients with cancer. The Director, Quality Analytical Technical Lead, Small Molecule serves as the global accountable owner for analytical lifecycle management of assigned commercial products, providing technical leadership across methods, specifications, stability, investigations, regulatory support, and internal and external QC networks.
Responsibilities
- 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
- 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
Skills
- Bachelor's degree and 10+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience required
- Strong PC literacy required; 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
- 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%
- 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
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan.
- 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.
- All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan.
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Company Overview
Company H1B Sponsorship