CMC质量总监

Director, CMC Quality

Position Summary

BrainChild 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.

BrainChild 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.

Responsibilities

CMC Quality Leadership

• 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 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)

• 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 to support the company's growth and evolving product portfolio.

Product Quality Strategy

• Lead 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.

• Provide Quality oversight of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), In-process controls, release strategies, and continued process verification.

• Assess quality impact of manufacturing, analytical, facility, supplier, and process changes.

• Oversee 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.

QC Operations Oversight

• Provide 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.

• Oversee GMP sample lifecycle, retain programs, reference standards, and product traceability per applicable regulations and company procedures.

• Lead 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.

External Partner Quality Oversight

• 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.

Required Qualifications

• 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. commercialization.

• 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.

Preferred Qualifications

• Ph.D., Pharm.D., or other advanced scientific degree.

• Experience implementing contamination control strategies aligned with EU GMP Annex 1.

• Experience supporting regulatory submissions including INDs, BLAs, MAAs, and post-approval lifecycle changes.

Travel

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

Originally posted on Himalayas