Associate Director, Technical Operations (Pharmaceutical Packaging)

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 Associate Director, Technical Operations (Pharmaceutical Packaging) 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 cause analysis, change control, and CAPA activities related to packaging. Ensure packaging changes are assessed for technical, regulatory, operational, and supply impact prior to implementation. Documentation and Technical Review Author, review and approve the drafting of packaging documentation, including: Packaging specifications Component drawings Batch records Validation protocols and reports Technical transfer documentation Packaging instructions Ensure documentation is complete, accurate, and compliant with regulatory requirements. Education/Experience Requirements: M.S. or B.S. degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or related technical field required. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered. 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. Additional Skills/Experience: 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. Strong professional experience in a similar role within the pharmaceutical industry, preferably in injectables. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. Excellent decision-making and collaboration skills with strong attention to detail. Six Sigma and statistical knowledge is a plus. Ability to travel 10%-20% domestically and internationally. #LI-Remote Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer Total Rewards Offerings : Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. Benefits: Our benefits include 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 and generous paid time off. Compensation : Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. Target Base Pay Range: $150,000.00 - $195,000.00 *This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location. Travere will accept applications on an ongoing basis until a candidate is selected for the position. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [email protected] . Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.