Sr. Manager, Packaging & Labeling (Remote)

About the role

Cabaletta Bio is recruiting a remote Sr. Manager, Packaging & Labeling who reports to the Director, Network Planning. The role is the primary technical expert for designing, qualifying and transferring clinical and commercial label, artwork and packaging configurations across the company's global network of CDMOs, ensuring a robust chain of identity and chain of custody.

Key responsibilities

• Develop and standardize patient-specific labeling strategies across CMOs, clinical sites, depots and logistics providers, with oversight but no direct operational ownership
• Define label readability, human factors and data element standards, and ensure labels perform under cryogenic, condensation and transport conditions
• Review packaging specifications, labeling content and artwork for accuracy and compliance, and own SOPs, specifications, change control, deviations/CAPAs and reconciliation/destruction oversight
• Ensure labeling meets global regulatory requirements (FDA, EMA, Annex 13) and support IND/BLA filings and inspections
• Establish validation strategies for 21 CFR Part 11 and GMP, including IQ/OQ/PQ reviews and vendor validation documentation
• Design, qualify and validate patient-specific, temperature-controlled packaging (cryogenic shippers, LN2 dewars, ambient kits) and assess risks of packaging failures
• Support scale-up and network expansion, including new CMOs, new regions and the clinical-to-commercial transition

Required profile

• Bachelor's degree or equivalent (Engineering, Supply Chain, Packaging Science or related field preferred)
• 5-7 years of experience in labeling, packaging or artwork management in biopharma, cell therapy or GMP manufacturing; autologous cell and gene therapy experience ideal
• Ability to manage cross-functional teams and external vendors/CMOs without direct operational authority

Required skills

• Working knowledge of FDA, EMA and Annex 13 labeling requirements; IND/BLA filing experience preferred
• Experience with 21 CFR Part 11, GMP and validation (IQ/OQ/PQ)
• Familiarity with cryogenic or cold-chain packaging and patient-specific cell therapy supply chains strongly preferred
• Project management, documentation and change-control skills

What we offer

• Health and retirement benefits
• PTO
• Stock option plans