{"id":735246,"url":"https://alion.io/job/brainchildbio-director-cmc-quality","title":"Director, CMC Quality","company":{"id":669674,"name":"BrainChild Bio","domain":"brainchildbio.com","url":"https://alion.io/company/brainchildbio","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":190000,"max":210000,"currency":"USD","period":"year","gross":null,"usd_annual":210000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-27T15:54:43Z","employer_posted_date":"2026-08-27","last_verified_at":"2026-10-31T04:41:47Z","board_verified":true,"closed_at":null,"days_open":64,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":64},"description":"Director, CMC Quality\nPosition Summary\nBrainChild Bio is seeking an experienced Director, CMC Quality to provide strategic quality leadership across the development and lifecycle management of its cell therapy programs. This role serves as the CMC Quality lead, ensuring phase-appropriate quality oversight, robust control strategies, QC Operations and compliance with regulatory requirements throughout the product lifecycle.\nBrainChild Bio is a clinical-stage biotechnology company leading the field in the development of CAR T cell therapies for tumors in the central nervous system (CNS). We are kids-first, prioritizing devastating pediatric brain tumors, with a pipeline that extends our technology platform to adult indications, including glioblastoma and brain metastases. Every member of our team plays a direct role in bringing innovative therapies to patients and familiars with urgent unmet medical needs.\nResponsibilities\nCMC Quality Leadership\nProvide 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 to ensure scientifically sound, risk-based quality decisions throughout the lifecycle of BrainChild Bio’s cell therapy products including but not limited to development, technology transfer, characterization, validation, and continued process verification (CPV)\nReview and approve CMC regulatory submissions, development and validation documentation, technical reports, comparability assessments, and regulatory responses. \nSupport health authority inspections and interactions, and other due diligence activities.\nDrive continuous improvement of CMC Quality systems, processes, and organizational capabilities to support the company's growth and evolving product portfolio.\nProduct Quality Strategy\nLead development and lifecycle management of product quality and risk-based control strategies aligned with QbD, QRM, ICH, and global regulatory expectations for product quality focus areas across lifecycle management including but not limited to stability, shipping, comparability, and specifications. \nProvide Quality oversight of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), In-process controls, release strategies, and continued process verification. \nAssess quality impact of manufacturing, analytical, facility, supplier, and process changes.\nOversee the development and lifecycle management of product, raw material, in-process, release, stability specifications and analytical acceptance criteria, ensuring they are scientifically justified, risk-based, aligned with process capability, and appropriate to support product development, regulatory submissions and post-approval lifecycle management.\nQC Operations Oversight\nProvide strategic Quality oversight for QC support activities performed by internal Analytical Development laboratories and outsourced QC operations (e.g., CTLs/CDMOs) supporting clinical and commercial products, including testing, analytical method lifecycle management, laboratory investigations, deviations, OOS/OOT events, CAPAs and quality/compliance metrics.\nOversee GMP sample lifecycle, retain programs, reference standards, and product traceability per applicable regulations and company procedures.\nLead Quality oversight of sterility assurance programs, including contamination control, aseptic processing, environmental monitoring, cleanroom qualification, microbiological controls, and Annex 1 compliance from initial risk assessments through contamination investigations and continuous improvement.\nExternal Partner Quality Oversight\nProvide Quality oversight for CTLs, CDMOs, and other external partners through vendor qualification, audits, governance, quality agreements, technology transfer, manufacturing support, investigations, and change management.\nRequired Qualifications\nBachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Microbiology, Biochemistry, or a related scientific discipline; advanced degree preferred. \n10+ years of progressive Quality experience in biotechnology, biologics, or advanced therapies, including at least 5 years supporting cell therapy or ATMP products. \nDemonstrated expertise supporting autologous and/or allogeneic cell therapy manufacturing, analytical testing, and lifecycle management. commercialization. \nDemonstrated 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.\nExtensive knowledge of GMP, GCP, ICH guidelines, FDA, EMA, and global regulatory requirements applicable to cell and gene therapies. \nExperience supporting regulatory inspections, Health Authority interactions, and maintaining inspection readiness. \nExcellent leadership, communication, and cross-functional collaboration skills, with demonstrated ability to influence internal and external stakeholders. \nProven ability to manage competing priorities, lead complex technical quality initiatives, and make sound, risk-based decisions in a fast-paced, evolving environment. \nPreferred Qualifications\nPh.D., Pharm.D., or other advanced scientific degree. \nExperience implementing contamination control strategies aligned with EU GMP Annex 1. \nExperience supporting regulatory submissions including INDs, BLAs, MAAs, and post-approval lifecycle changes. \nTravel\nApproximately 30-40% travel to CDMOs, Contract Testing Laboratories, suppliers, company locations, and regulatory or business 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