or apply directly on Brainchildbio's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 20 days Brainchildbio's roles stay open a median of 35 days
- Reposted
- No
- Salary listed
- No 0% of Brainchildbio's roles list one
- Ghost-job risk at Brainchildbio
- low 0 stale, 0 reposted of 7 open
- Hiring momentum
- 10 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Brainchildbio's own lever board since 2026-08-04. Full hiring picture for Brainchildbio.
About this role
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.
- benefits
- 1/5
- freshness
- 4/5
- career value
- 5/5
- role clarity
- 5/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Brainchildbio as an employer.
What you need
- 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
Worth weighing
- 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
Summarised from Brainchildbio's posting. Read the full original.
Listed by Brainchildbio on their lever job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
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