Head of CMC Quality, Cell Therapy and Regulatory Leadership

BrainChild Bio, Inc.

Seattle (WA)

On-site

USD 180,000 - 270,000

Full time

4 days ago

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Job summary

BrainChild Bio in Seattle is seeking an experienced Director, CMC Quality to provide strategic quality leadership across development and lifecycle management of its cell therapy programs. As the CMC Quality lead, you will shape phase-appropriate quality oversight, robust control strategies, and regulatory compliance throughout the product lifecycle.

You will collaborate with Process and Analytical Development, MSAT, Regulatory Affairs, Supply Chain and external partners to ensure risk-based

Qualifications

10+ years of progressive Quality experience in biotechnology or related field.
5+ years supporting cell therapy or ATMP products.
Experience with autologous and/or allogeneic cell therapy manufacturing and lifecycle management.
Expertise in CMC Quality including QbD, QRM, control strategy, QC oversight, analytical method lifecycle, specs, stability, sterility, contamination control.
Extensive knowledge of GMP, GCP, ICH, FDA/EMA requirements for cell and gene therapies.
Experience with regulatory inspections and health authority interactions.
Strong leadership and cross-functional collaboration skills.

Responsibilities

Provide strategic quality leadership as the Quality representative on cross-functional teams across lifecycle.
Review and approve CMC regulatory submissions, development and validation documentation, and regulatory responses.
Support health authority inspections and interactions, and due diligence activities.
Drive continuous improvement of CMC Quality systems and organizational capabilities.