[Hiring] Senior Manager, Packaging & Labeling @Cabaletta Bio

Role 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

• 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.

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.

Benefits

• Competitive benefits
• PTO
• Stock option plans

Company Description

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.