Senior Manager, Packaging & Labeling

🕒 September 1

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Serve as the primary technical expert for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across the global CDMO network • Ensure robust chain of identity (COI) and chain of custody (COC) • Develop and standardize patient-specific labeling strategies across CMOs, clinical sites, depots, and logistics providers • Oversee consistent labeling 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 and support IND/BLA filings and inspections • Establish validation strategies for 21 CFR Part 11 and GMP compliance • Review and approve IQ/OQ/PQ and vendor validation documentation • Design, qualify, and validate patient-specific, temperature-controlled packaging systems • 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, new CMOs, new regions, and the clinical-to-commercial transition • Perform other related duties as assigned

🎯 Requirements

• 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 • 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