Director, CMC Quality — Cell Therapy Strategy Leader

BrainChild Bio, Inc.

United States

À distance

USD 190 000 - 210 000

Plein temps

14 jours+

Générateur de candidature

Une candidature conçue pour ce poste — un CV et une lettre de motivation personnalisés qui correspondent à l’offre.

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Résumé du poste

BrainChild Bio is seeking an experienced Director, CMC Quality to provide strategic quality leadership across 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.

The role requires 10+ years in biotech quality, strong leadership, and extensive knowledge of CMC, QbD, QRM, and

Qualifications

Bachelor’s or Master’s degree in a life science or engineering discipline. Advanced degree preferred.
10+ years in biotechnology/biologics/advanced therapies quality.
Experience supporting cell therapy manufacturing, analytics, and lifecycle management.
Expertise in CMC quality, QbD, QRM, control strategies, and specifications.
Knowledge of GMP, GCP, ICH, FDA/EMA regulatory requirements for cell therapies.
Experience with regulatory inspections and health authority interactions.

Responsabilités

Provide strategic quality leadership as CMC Quality representative across development and lifecycle management.
Review and approve CMC regulatory submissions and technical reports.
Support HA inspections and due diligence activities.
Drive continuous improvement of CMC quality systems and capabilities.
Oversee QC operations, analytical development, and supplier quality oversight.
Develop and maintain product quality strategies, specifications, and lifecycle management.