Senior Manager, Global Labeling & Packaging

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Cabaletta Bio is seeking a Sr. Manager, Packaging & Labeling to lead design, qualification, and tech transfer of clinical and commercial labeling and packaging across our global CDMO network. You will ensure COI/COC integrity and regulatory readiness.

The role requires 5–7 years in labeling/packaging within regulated GMP environments, knowledge of FDA/EMA Annex 13, and hands-on IQ/OQ/PQ validation. You will collaborate cross-functionally with manufacturing, quality, and logistics to support

Qualifications

• Bachelor's degree or equivalent in Engineering, Supply Chain, Packaging Science, or a related field.
• 5–7 years in labeling, packaging, or artwork management in biopharmaceutical, cell therapy, or regulated GMP environments.
• Working knowledge of FDA, EMA, and Annex 13 labeling requirements; IND/BLA experience preferred.
• Experience with 21 CFR Part 11, GMP, and validation practices (IQ/OQ/PQ).
• Familiarity with cryogenic or cold-chain packaging and autologous cell therapy supply chains strongly preferred.
• Demonstrated ability to manage cross-functional relationships and external vendor/CMO oversight without direct operational authority.
• Strong project management, documentation, and change-control skills.

Responsibilities

• Develop and standardize patient-specific labeling strategies across CMOs, clinical sites, depots, and logistics providers, providing oversight to ensure consistent execution without direct operational ownership.
• Define standards for label readability, human factors, and required data elements; ensure label performance under cryogenic, condensation, and transport conditions.
• Review packaging specifications, labeling content, and artwork for accuracy and compliance; own SOPs, specifications, and governance, including change control, deviations/CAPAs, and reconciliation/destruction oversight.
• Ensure labeling meets global regulatory requirements (FDA, EMA, Annex 13, country-specific rules) and support IND/BLA filings and inspections
• Establish validation strategies ensuring 21 CFR Part 11 and GMP compliance, including review and approval of IQ/OQ/PQ and vendor validation documentation
• Design, qualify, and validate patient-specific, temperature-controlled packaging systems (cryogenic shippers, LN2 dewars, ambient kits; e.g., ≤ -150°C vapor phase LN2, refrigerated) to maintain chain of identity and product integrity.
• Ensure packaging supports vein-to-vein logistics timing constraints; manage container closure integrity and compatibility with cryogenic storage and handling.
• Perform risk assessments for packaging failures impacting patient material.
• Support scale-up network expansion, including new CMOs, new regions, and the clinical-to-commercial transition.
• Other related duties, as assigned.

Skills

Project management

Vendor oversight

Cross-functional collaboration

Documentation

Change control

Labeling knowledge

GMP compliance

Education

Bachelor's degree in Engineering/Science

Tools

IQ/OQ/PQ documentation

GxP systems

Job description

Cabaletta Bio is seeking a Sr. Manager, Packaging & Labeling to lead design, qualification, and tech transfer of clinical and commercial labeling and packaging across our global CDMO network. You will ensure COI/COC integrity and regulatory readiness.

The role requires 5–7 years in labeling/packaging within regulated GMP environments, knowledge of FDA/EMA Annex 13, and hands-on IQ/OQ/PQ validation. You will collaborate cross-functionally with manufacturing, quality, and logistics to support