Director, Quality Analytical Technical Lead – Small Molecule

🔥 17 horas atrás

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Serve as the global point of contact and accountable owner for analytical lifecycle management of assigned commercial small-molecule products • Provide governance and technical leadership across drug substance, drug product, and critical raw materials/reagents • Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST • Lead analytical investigations and performance issues, including OOS/OOT/OOE, atypical results, and invalidations • Ensure root cause analysis, CAPA, and 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 and align actions with Quality, Regulatory, and Supply Chain • Own global processes for commercial analytical methods, specifications, stability programs, and retest period/shelf-life governance • Take over submission-ready analytical documentation from development • Ensure alignment between analytical control strategy and product risk profile, including small-molecule impurity control • Provide analytical SME leadership for Rest of World filings and post-approval variations • Partner with Regulatory CMC on health-authority interactions and responses • Govern internal QC and external QC networks, including expectations, metrics, investigation quality, and escalation pathways • Contribute to audits and inspections as the product analytical SME and ensure inspection readiness • Influence lab capacity planning and capability upgrades using a risk-based approach

🎯 Requisitos

• Bachelor’s degree required • 10+ years of biopharmaceutical experience with significant commercial lifecycle responsibility required • Demonstrated leadership in GMP QC and/or analytical sciences • Experience with small-molecule methods, including HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, and genotoxic impurities as applicable • Strong working knowledge of method validation/verification • Strong working knowledge of stability trends and statistical evaluation • Strong working knowledge of specification lifecycle management • Strong working knowledge of data integrity • Ability to lead through influence in a matrix organization • Strong stakeholder management and negotiation skills • Strong technical writing skills and ability to deliver inspection-defensible narratives • Program and risk management mindset • Ability to prioritize in supply-constrained environments • Strong PC literacy • Proficiency with MS Office, including Outlook, Word, Excel, and PowerPoint • Willingness to travel up to 20%

🏖️ Benefícios

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness program • Equal opportunity employer • Reasonable accommodation in the job application process