Remote Senior Manager, Packaging & Labeling (Biotech)

Cabaletta Bio; Missouri; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock options

Job summary

Cabaletta Bio is seeking a Sr. Manager, Packaging & Labeling to lead the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across a global CDMO network.

You will ensure robust COI/COC and adherence to regulatory standards. Ideal candidates have 5–7 years in labeling/packaging within regulated GMP environments, with strong project management and cross-functional collaboration skills.

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.

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.

Education

Bachelor's degree or equivalent

5–7 years experience in labeling, packaging, or artwork management

Job description

Cabaletta Bio is seeking a Sr. Manager, Packaging & Labeling to lead the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across a global CDMO network.

You will ensure robust COI/COC and adherence to regulatory standards. Ideal candidates have 5–7 years in labeling/packaging within regulated GMP environments, with strong project management and cross-functional collaboration skills.