Director, Quality Analytical Technical Lead – Small Molecule

🕒 Agosto 17

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $168.000 - $228.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

👻 Score fantasma 6%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

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