Senior Pharmaceutical Packaging Engineer, Technical Operations

🕒 il y a 26 jours

🏄 California – Distant

🏄 California – Remote

💵 $150 000 - $195 000 / an

⏰ Temps Plein

🟠 Senior

⚙️ Opérations

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Travere Therapeutics

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2013

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Travere Therapeutics est une entreprise biopharmaceutique engagée dans l'identification, le développement et la fourniture de thérapies révolutionnaires pour les personnes atteintes de maladies rares, en particulier celles liées aux troubles rénaux et métaboliques rares. L'entreprise se concentre fortement sur l'avancement de la science dans ces domaines, avec un pipeline qui inclut des traitements pour des affections telles que la néphropathie à IgA et la glomérulosclérose segmentaire focale. Avec l'approbation complète par la FDA américaine de son traitement non immunosuppresseur pour la néphropathie à IgA, Travere Therapeutics continue de fixer de nouveaux standards de soins. L'entreprise collabore avec la communauté des maladies rénales rares, y compris les organisations de défense des patients et les investigateurs d'essais cliniques, pour apporter de l'espoir aux patients atteints de ces affections sérieuses.

Description

• Responsible for the design, development, qualification, implementation and lifecycle management of packaging systems for pharmaceutical combination products • Serve as the packaging subject matter expert (SME) and collaborate with commercial packaging organization (CPO) • Lead the development and finalization of packaging configurations, including primary packaging, labels, cartons, shippers, and ancillary components • Oversee the development of user-centric secondary packaging that facilitates patient adherence and meets Human Factors (HF) requirements • Drive innovation in sustainable packaging materials without compromising product stability or sterile barrier integrity • Ensure packaging configurations are commercially feasible, manufacturable, cost effective, and aligned with supply chain and distribution requirements • Develop, review, and approve packaging specifications, component drawings, bills of materials, and packaging instructions • Lead packaging technology transfer activities from development through clinical and commercial manufacturing • Ensure successful transfer of packaging processes, specifications, and operational requirements to external partners • Lead packaging process optimization and continuous improvement initiatives • Design and execute comprehensive Transportation Simulation Studies (per ASTM D4169 or ISTA standards) to ensure product integrity across global shipping lanes • Author and defend Thermal Mapping studies and Lane Qualifications for global distribution hubs

🎯 Exigences

• M.S. or B.S. degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or related technical field required • Minimum of 8 years of pharmaceutical, biotech, or medical device packaging experience • Direct experience supporting clinical and commercial packaging operations • Demonstrated experience working with CPOs • Experience supporting packaging technology transfer and commercialization • Experience supporting packaging validation and qualification • Strong knowledge of pharmaceutical packaging systems, including primary packaging, labels, cartons, and shippers • Thorough understanding of cGMP and regulatory requirements • Knowledge of FDA, EMA, and global packaging regulations • Experience supporting serialization and traceability requirements (DSCSA preferred) • Understanding of cold chain packaging and distribution • Experience reviewing packaging batch records, specifications, and validation documentation • Experience in managing late phase / commercial programs and post-launch lifecycle management

🏖️ Avantages

• premium health • financial, work-life and well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off