Remote: Senior CMC Team Lead, Cell Therapy

Valid8 Financial, Inc.

Philadelphia (Philadelphia County)

On-site

USD 180,000 - 275,000

Full time

14 days+

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Benefits offered by this job

Stock option plans

Competitive benefits

Paid time off (PTO)

Job summary

Cabaletta Bio is seeking an experienced and strategic CMC Team Leader to provide cross-functional leadership for Chemistry, Manufacturing, and Controls across clinical and commercial-stage biologic products. This role partners with Technical Operations and other functions to advance programs from development through commercialization.

The ideal candidate has 12+ years in CMC, with biologics, and experience leading regulatory submissions and late-stage readiness.

Qualifications

Advanced degree in life sciences or related field; PhD/MS preferred.
12+ years of CMC experience in biotech/pharma.
CMC lead or cross-functional leadership experience.
Strong background in biologics development and regulatory strategy.
Excellent communication to technical and executive audiences.

Responsibilities

Lead CMC strategy from development through registration and commercialization.
Lead cross-functional CMC team across PD, Analytical, Quality, Regulatory, and Supply Chain.
Develop integrated CMC development plans covering process and analytics, manufacturing, and lifecycle strategy.
Drive risk, timelines, priorities, and resources.
Ensure CMC plans align with clinical, regulatory, and commercial objectives.