Senior Packaging & Labeling Manager, Biotech (Remote)

Valid8 Financial, Inc.; Kentucky; On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Stock options

Competitive benefits

Paid time off

Job summary

Cabaletta Bio seeks a Sr. Manager, Packaging & Labeling to lead design, qualification, and tech transfer of clinical and commercial labeling and packaging across a global CDMO network.

The role ensures COI/COC integrity, supports IND/BLA filings, and drives 21 CFR Part 11 and GMP compliant packaging programs for autologous cell therapy, including cryogenic and cold-chain solutions. Remote work is possible with collaboration across functions and external partners; the team emphasizes rapid

Qualifications

• Bachelor's degree or equivalent in Engineering, Packaging, or related field.
• 5–7 years labeling/packaging/artwork management in biopharma or GMP.
• Familiarity with FDA/EMA/Annex 13 labeling requirements; IND/BLA experience preferred.
• Experience with 21 CFR Part 11, GMP, and validation (IQ/OQ/PQ).
• Knowledge of cryogenic/cold-chain packaging and autologous cell therapy supply chains.
• Ability to manage cross-functional relationships with external vendors/CMOs.
• Strong project management, documentation, and change-control skills.

Responsibilities

• Develop and standardize patient-specific labeling across CMOs and sites.
• Define label readability standards and ensure performance under cryogenic conditions.
• Review packaging specs and artwork; own SOPs, change control, and deviations.
• Ensure labeling meets global regulatory requirements; support IND/BLA filings.
• Establish validation strategies for 21 CFR Part 11 and GMP; review IQ/OQ/PQ docs.
• Design, qualify, and validate cryogenic packaging systems to preserve product integrity.
• Support scale-up network expansion and clinical-to-commercial transition.
• Perform risk assessments for packaging failures affecting patient materials.
• Manage cross-functional relationships and external vendor oversight.

Skills

Cross-functional collaboration

Project management

Documentation

Change control

Vendor/CMO oversight

Regulatory labeling knowledge

Education

Bachelor's degree in Engineering/Packaging/Science

Tools

IQ/OQ/PQ

GMP validation tools

Job description

Cabaletta Bio seeks a Sr. Manager, Packaging & Labeling to lead design, qualification, and tech transfer of clinical and commercial labeling and packaging across a global CDMO network.

The role ensures COI/COC integrity, supports IND/BLA filings, and drives 21 CFR Part 11 and GMP compliant packaging programs for autologous cell therapy, including cryogenic and cold-chain solutions. Remote work is possible with collaboration across functions and external partners; the team emphasizes rapid