Director, CMC Quality

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $190k - $210k / year

⏰ Full Time

🔴 Lead

👔 Director

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BrainChild Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $300k Grant - BrainChild Bio on 2025-01

Healthcare • Biotechnology • Pharmaceuticals

<BrainChild Bio> is a clinical-stage biotechnology company developing CAR T-cell therapies targeting tumors in the central nervous system (CNS). The company prioritizes pediatric brain tumors while extending its platform to adult indications such as glioblastoma and brain metastases, aiming to advance novel cell therapies through the clinic and translate its science broadly to improve outcomes for children and adults with CNS cancers.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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