Sr. Manager, Packaging & Labeling: Tell Me More

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

Reporting to the Director, Network Planning, the Sr. Manager, Packaging & Labeling serves as the primary technical expert for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across our global network of Contract Development and Manufacturing Organizations (CDMOs), ensuring robust chain of identity (COI) and chain of custody (COC) throughout.

Responsibilities Include

Labeling

• 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

Packaging

• 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.

Required Qualifications

• Bachelor's degree or equivalent (preferred concentration in Engineering, Supply Chain, Packaging Science, or a related field).
• 5–7 years of experience in labeling, packaging, or artwork management within biopharmaceutical, cell therapy, or regulated GMP manufacturing environments; relevant experience in autologous cell & gene therapy is ideal.
• Working knowledge of FDA, EMA, and Annex 13 labeling requirements; experience supporting IND/BLA filings preferred.
• Experience with 21 CFR Part 11, GMP, and validation practices (IQ/OQ/PQ).
• Familiarity with cryogenic or cold-chain packaging and patient-specific (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.

• Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.