Director, CMC Quality

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $190 000 - $210 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 22%

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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BrainChild Bio

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11 - 50 employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €300 000 Grant - BrainChild Bio en 2025-01

Healthcare • Biotechnology • Pharmaceuticals

<BrainChild Bio> est une entreprise de biotechnologie en phase clinique développant des thérapies par cellules CAR T ciblant les tumeurs du système nerveux central (SNC). L'entreprise accorde la priorité aux tumeurs cérébrales pédiatriques tout en étendant sa plateforme à des indications adultes telles que le glioblastome et les métastases cérébrales, dans le but de faire progresser de nouvelles thérapies cellulaires à travers les essais cliniques et de traduire ses découvertes scientifiques de manière générale pour améliorer les résultats pour les enfants et les adultes atteints de cancers du SNC.

Description

• Provide strategic quality leadership as the Quality representative on cross-functional teams, partnering with Process and Analytical Development, MSAT, Regulatory Affairs, Supply Chain, and external partners • Ensure scientifically sound, risk-based quality decisions throughout the lifecycle of cell therapy products, including development, technology transfer, characterization, validation, and continued process verification (CPV) • Review and approve CMC regulatory submissions, development and validation documentation, technical reports, comparability assessments, and regulatory responses • Support health authority inspections and interactions, and other due diligence activities • Drive continuous improvement of CMC Quality systems, processes, and organizational capabilities • Lead development and lifecycle management of product quality and risk-based control strategies aligned with QbD, QRM, ICH, and global regulatory expectations • Provide Quality oversight of CQAs, CPPs, CMAs, in-process controls, release strategies, and continued process verification • Assess quality impact of manufacturing, analytical, facility, supplier, and process changes • Oversee product, raw material, in-process, release, and stability specifications and analytical acceptance criteria • Provide strategic Quality oversight for internal Analytical Development laboratories and outsourced QC operations, including testing, analytical method lifecycle management, investigations, deviations, OOS/OOT events, CAPAs, and quality/compliance metrics • Oversee GMP sample lifecycle, retain programs, reference standards, and product traceability • Lead Quality oversight of sterility assurance programs, contamination control, aseptic processing, environmental monitoring, cleanroom qualification, microbiological controls, and Annex 1 compliance • Provide Quality oversight for CTLs, CDMOs, and other external partners through vendor qualification, audits, governance, quality agreements, technology transfer, manufacturing support, investigations, and change management

🎯 Exigences

• Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Microbiology, Biochemistry, or a related scientific discipline; advanced degree preferred • 10+ years of progressive Quality experience in biotechnology, biologics, or advanced therapies, including at least 5 years supporting cell therapy or ATMP products • Demonstrated expertise supporting autologous and/or allogeneic cell therapy manufacturing, analytical testing, and lifecycle management • Demonstrated expertise in CMC Quality including QbD, QRM, control strategy development, QC oversight, analytical method lifecycle management, specifications, stability, sterility assurance, contamination control, process development, technology transfer and process validation • Extensive knowledge of GMP, GCP, ICH guidelines, FDA, EMA, and global regulatory requirements applicable to cell and gene therapies • Experience supporting regulatory inspections, Health Authority interactions, and maintaining inspection readiness • Excellent leadership, communication, and cross-functional collaboration skills, with demonstrated ability to influence internal and external stakeholders • Proven ability to manage competing priorities, lead complex technical quality initiatives, and make sound, risk-based decisions in a fast-paced, evolving environment • Experience implementing contamination control strategies aligned with EU GMP Annex 1 • Experience supporting regulatory submissions including INDs, BLAs, MAAs, and post-approval lifecycle changes

🏖️ Avantages

• Approximately 30–40% travel to CDMOs, Contract Testing Laboratories, suppliers, company locations, and regulatory or business meetings

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