Department:
106800
Technical Operations Location:
San Diego, USA
- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.
Our work is rewarding
- both professionally and personally
- because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission
- to identify, develop and deliver life-changing therapies to people living with rare disease.
We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Senior Pharmaceutical Packaging Engineer, Technical Operations is responsible for the design, development, qualification, implementation and lifecycle management of packaging systems for pharmaceutical combination products. The role will serve as the packaging subject matter expert (SME) and collaborate with commercial packaging organization (CPO) to ensure that the pharmaceutical packaging meets product protection, global regulatory, manufacturing, and distribution requirements, supporting programs from development through commercialization. This position collaborates closely with colleagues in Technical Operations, Quality, Regulatory, Supply Chain, and Commercial supporting the corporate goals for development and commercialization of a combination product for a rare disease indication.
Responsibilities:
Packaging Design and Development 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. Ensure packaging configurations support product integrity, stability, sterility, and protection, throughout storage and distribution. Lead design and implementation of packaging solutions for controlled temperature storage. Provide technical guidance on packaging component selection, including compatibility, and material suitability. Packaging Technology Transfer and Implementation 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. Review and approve packaging batch records, specifications, protocols, and validation documentation. Ensure packaging lines and processes are properly qualified and validated. Lead packaging process optimization and continuous improvement initiatives. Packaging Qualification and Validation Lead development and execution of packaging validation strategies. Ensure packaging processes are capable, repeatable, and compliant. Design and execute comprehensive Transportation Simulation Studies (per ASTM D4169 or ISTA standards) to ensure product integrity across global shipping lanes. Support shipping validation and distribution qualification activities. Ensure packaging systems maintain product quality throughout the distribution lifecycle. Support development and execution of risk assessments, including packaging-related design, process, and distribution risks. Commercialization and Launch Readiness Ensure packaging solutions support commercialization requirements, including labeling compliance, serialization, and traceability. Support lifecycle management activities, including packaging updates, improvements, and change implementation. Serialization, Traceability, and Distribution Support Ensure packaging configurations comply with serialization and traceability requirements, including DSCSA and global serialization regulations. Ensure packaging supports distribution through specialty pharmacy, wholesale, and third-party logistics networks. Support cold chain packaging and distribution requirements where applicable. Develop and validate shipping systems for temperature-sensitive products (2-8C) Implement end-to-end cold chain monitoring strategies, utilizing advanced data loggers and real-time tracking to mitigate excursion risks. Author and defend Thermal Mapping studies and Lane Qualifications for global distribution hubs Quality and Regulatory Compliance Ensure all packaging activities comply with current cGMP, FDA, EMA, and applicable global regulatory requirements as well as other regulatory requirements. Ensure packaging configurations comply with applicable labeling and packaging regulations. Lead and/or contribute to the preparation and review of regulatory submissions, including packaging-related documentation. Participate in internal audits, external partner audits, and regulatory inspections as the packaging subject matter expert. Support deviation investigations, root... For full info follow application link. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
