[Hiring] Director, CMC Quality @BrainChild Bio

Role Description

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.

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.
  • Ensure scientifically sound, risk-based quality decisions throughout the lifecycle of BrainChild Bio’s cell therapy products.
  • 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.
• 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.
  • Provide Quality oversight of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Critical Material Attributes (CMAs).
  • 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.
• QC Operations Oversight
  • Provide strategic Quality oversight for QC support activities performed by internal Analytical Development laboratories and outsourced QC operations.
  • Oversee GMP sample lifecycle, retain programs, reference standards, and product traceability.
  • Lead Quality oversight of sterility assurance programs, including contamination control and aseptic processing.
• External Partner Quality Oversight
  • Provide Quality oversight for CTLs, CDMOs, and other external partners through vendor qualification, audits, and quality agreements.

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.
• Demonstrated expertise in CMC Quality including QbD, QRM, control strategy development, QC oversight, and analytical method lifecycle management.
• 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.
• Proven ability to manage competing priorities and lead complex technical quality initiatives.

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.

Compensation

• $190,000 - $210,000 a year