CMC Quality Director — Cell Therapy Leadership

BrainChild Bio, Inc.; Northern (KY); Hybrid; USD 190,000 - 210,000; Full time

Job summary

BrainChild Bio, Inc. is seeking a Director of CMC Quality to lead strategic quality oversight across cell therapy programs. You will chair cross-functional teams, shape CQAs/CPPs/CMAs, and ensure GMP/ICH compliance from development through lifecycle management.

The role requires deep experience in CMC quality, regulatory interactions, and a track record of leading quality initiatives in autologous/allogeneic cell therapy. Travel up to 30-40% is expected.

Qualifications

• Bachelor's or Master's in Life Sciences, Engineering, Pharmacy, or related field.
• 10+ years in biotechnology quality with 5+ years in cell therapy.
• CMC quality expertise including QbD, QRM, control strategy.
• GMP, GCP, ICH knowledge; regulatory inspections experience.
• Strong leadership and cross-functional collaboration.

Responsibilities

• Provide strategic quality leadership across lifecycle stages.
• Review CMC submissions and regulatory responses.
• Oversee QC and analytical method lifecycle management.
• Manage external partner quality oversight and audits.
• Drive continuous improvement of quality systems.

Skills

CMC Quality

Regulatory Submissions

GMP/ICH

Quality Systems

Cell Therapy

Tech Transfer

Process Validation

Leadership

Education

Life Sciences degree

Advanced degree preferred

Job description

BrainChild Bio, Inc. is seeking a Director of CMC Quality to lead strategic quality oversight across cell therapy programs. You will chair cross-functional teams, shape CQAs/CPPs/CMAs, and ensure GMP/ICH compliance from development through lifecycle management.

The role requires deep experience in CMC quality, regulatory interactions, and a track record of leading quality initiatives in autologous/allogeneic cell therapy. Travel up to 30-40% is expected.