Director, CMC Quality

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $190.000 - $210.000 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 23%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Warum dieser Wert:

• Seit 76 Tagen offen.

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BrainChild Bio

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

💰 €300.000 Grant - BrainChild Bio im 2025-01

Healthcare • Biotechnology • Pharmaceuticals

<BrainChild Bio> ist ein biotechnologisches Unternehmen in der klinischen Phase, das CAR T-Zelltherapien zur Behandlung von Tumoren im Zentralnervensystem (ZNS) entwickelt. Das Unternehmen legt den Schwerpunkt auf pädiatrische Hirntumoren, erweitert jedoch seine Plattform auf Erwachsenenerkrankungen wie Glioblastom und Hirnmetastasen. Ziel ist es, neuartige Zelltherapien durch klinische Prüfungen voranzutreiben und seine wissenschaftlichen Erkenntnisse breit zu übersetzen, um die Behandlungsergebnisse für Kinder und Erwachsene mit ZNS-Krebs zu verbessern.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

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