HHiring Reality
← Brainchildbio

Director, CMC Quality

Brainchildbio
Location
United States
Posted
24 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Microbiology, Biochemistry, or a related scientific discipline
  • 10+ years of progressive Quality experience in biotechnology, biologics, or advanced therapies
  • At least 5 years supporting cell therapy or ATMP products
  • 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 and maintaining inspection readiness
Nice to have
  • 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
What the job really is

The Director, CMC Quality at BrainChild Bio will lead quality oversight for cell therapy programs, ensuring compliance with regulatory requirements and implementing robust quality control strategies throughout the product lifecycle. The role involves collaboration with various departments to drive continuous improvement in CMC Quality systems and oversee QC operations, including external partners. This position requires strategic leadership in managing product quality and risk-based control strategies, as well as supporting regulatory submissions and inspections.

Things to weigh
  • Approximately 30-40% travel required to various locations and meetings
  • The role involves significant responsibility in a fast-paced, evolving environment
  • No specific salary or benefits information provided in the posting
Job score3/5
Benefits1/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency0/5

Applying to Brainchildbio?

See how your résumé matches this role — and tailor it from what actually gets interviews.