Sr. Manager, Packaging & Labeling
Cabaletta Bio
September 01, 2026
Remote
United States
Operations
Sr. Manager, Packaging & Labeling (Remote)
Responsibilities:
- Develop and standardize patient-specific labeling strategies across CDMOs, clinical sites, depots, and logistics providers; oversee consistent execution.
- Define standards for label readability, human factors, and required data elements; ensure performance under cryogenic, condensation, and transport conditions.
- Review packaging specifications, labeling content, and artwork for accuracy/compliance; own SOPs/specifications/governance (change control, deviations/CAPAs, 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 for 21 CFR Part 11 and GMP compliance (review/approval of IQ/OQ/PQ and vendor validation documentation).
- Design, qualify, and validate temperature-controlled patient-specific packaging systems to maintain chain of identity and product integrity.
- Ensure packaging supports vein-to-vein logistics timing; manage container closure integrity and cryogenic compatibility.
- Perform risk assessments for packaging failures impacting patient material.
- Support network scale-up (new CMOs/regions; clinical-to-commercial transition).
Qualifications:
- Bachelor’s degree or equivalent (preferred: Engineering, Supply Chain, Packaging Science, or related).
- 5–7 years in labeling/packaging/artwork management in biopharma/cell therapy/GMP; autologous cell & gene therapy experience ideal.
- Knowledge of FDA/EMA/Annex 13 labeling; IND/BLA support preferred.
- Experience with 21 CFR Part 11, GMP, validation (IQ/OQ/PQ).
- Cryogenic/cold-chain packaging and autologous cell therapy supply chain familiarity strongly preferred.
- Ability to manage cross-functional relationships and vendor/CMO oversight without direct operational authority.
- Strong project management, documentation, and change-control skills.
Benefits:
- Competitive benefits, PTO, and stock option plans.
Application instructions:
- Apply via https://www.cabalettabio.com/join-our-crew
Responsibilities:
- Develop and standardize patient-specific labeling strategies across CDMOs, clinical sites, depots, and logistics providers; oversee consistent execution.
- Define standards for label readability, human factors, and required data elements; ensure performance under cryogenic, condensation, and transport conditions.
- Review packaging specifications, labeling content, and artwork for accuracy/compliance; own SOPs/specifications/governance (change control, deviations/CAPAs, 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 for 21 CFR Part 11 and GMP compliance (review/approval of IQ/OQ/PQ and vendor validation documentation).
- Design, qualify, and validate temperature-controlled patient-specific packaging systems to maintain chain of identity and product integrity.
- Ensure packaging supports vein-to-vein logistics timing; manage container closure integrity and cryogenic compatibility.
- Perform risk assessments for packaging failures impacting patient material.
- Support network scale-up (new CMOs/regions; clinical-to-commercial transition).
Qualifications:
- Bachelor’s degree or equivalent (preferred: Engineering, Supply Chain, Packaging Science, or related).
- 5–7 years in labeling/packaging/artwork management in biopharma/cell therapy/GMP; autologous cell & gene therapy experience ideal.
- Knowledge of FDA/EMA/Annex 13 labeling; IND/BLA support preferred.
- Experience with 21 CFR Part 11, GMP, validation (IQ/OQ/PQ).
- Cryogenic/cold-chain packaging and autologous cell therapy supply chain familiarity strongly preferred.
- Ability to manage cross-functional relationships and vendor/CMO oversight without direct operational authority.
- Strong project management, documentation, and change-control skills.
Benefits:
- Competitive benefits, PTO, and stock option plans.
Application instructions:
- Apply via https://www.cabalettabio.com/join-our-crew