$195,000.

00 life insurance, paid time off United States, Hampshire, Manchester Aug 15, 2026

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, Biologics Drug Substance Manufacturing is responsible for providing technical expertise and operational leadership and support for biologic drug substance manufacturing from late-stage clinical development through commercialization. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities of a biologics product at external Contract Development and Manufacturing Organizations (CDMOs). The ideal candidate will have deep technical expertise in microbial fermentation, with a focus on downstream production, with demonstrated experience supporting late-stage development, Process Performance Qualification (PPQ), and Biologics License Application (BLA) submissions.

Responsibilities:

Provide technical oversight for drug substance manufacturing activities supporting late-stage clinical and commercial biologics programs at Travere's CDMOs. The focus will be on downstream production.\nReview and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization (PC) and PPQ protocols and reports.\nServe as technical resource for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.\nMonitor process performance data, identify process trends, and recommend improvements to increase process robustness, product quality, and manufacturing efficiency.\nSupport tech transfer and process scale-up at CDMOs.\nPartner with Regulatory Affairs to prepare technical documentation supporting CMC sections of IND, BLA, and regulatory agency responses.\nAuthor technical reports on a variety of manufacturing related subjects.\nSupport lifecycle management activities, including process optimization, post-approval changes, and continued process verification (CPV).\nAdditional duties assigned as needed.

Education/Experience Requirements:

Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required. Equivalent combination of education and applicable job experience may be considered. Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred.\n8+ years of relevant experience including biologics manufacturing, scale-up, and late stage drug development and commercialization.

Additional Skills/Experience:

The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.\nDriven, intelligent, passionate about making a difference for patients with rare diseases.\nStrong technical expertise in microbial fermentation and downstream processing for recombinant proteins or other biologic products is necessary. Experience in PEGylation is a plus.\nDemonstrated experience supporting late-stage clinical development through commercial manufacturing.\nDirect experience with QbD and supporting PPQ and process validation activities.\nExperience preparing or supporting the CMC manufacturing sections of Biologics License Applications (BLA).\nBroad knowledge of US and EU cGMP regulations, FDA and ICH guidance, technology transfer, process validation, and lifecycle management.\nExperience working with external CDMOs, including oversight of manufacturing campaigns and technical issue resolution.\nWorking knowledge of statistical process monitoring, process characterization, and quality risk management tools.\nExperience interpreting manufacturing data, troubleshooting process issues, and implementing scientifically sound solutions.\nExcellent technical writing and documentation skills, including preparation of protocols, reports, investigations, and regulatory documentation.\nStrong interpersonal and organizational skills and exceptional communication skills are required.\nAbility to travel 20

25% domestically and internationally.

\nAll positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego.\nNo role is expected to be 100% remote.

Total Rewards Offerings:

\nTravere 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 accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. 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Associate Director, Technical Operations, Biologics Drug Substance Manufacturing