Director, Quality Analytical Technical Lead – Small Molecule

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $168 000 - $228 000 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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BeOne Medicines

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

Description

• 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

🎯 Exigences

• 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%

🏖️ Avantages

• 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

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