Associate Director, Technical Operations, Biologics Drug Substance Manufacturing

About the role

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 and seek 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.

Responsibilities

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

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.) in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred.
• 8+ years of relevant experience including biologics manufacturing, scale-up, and late-stage drug development and commercialization.

Skills

• Strong technical expertise in microbial fermentation and downstream processing for recombinant proteins or other biologic products; experience in PEGylation is a plus.
• Demonstrated experience supporting late-stage clinical development through commercial manufacturing.
• Direct experience with QbD and supporting PPQ and process validation activities.
• Experience preparing or supporting the CMC manufacturing sections of Biologics License Applications (BLA).
• Broad knowledge of US and EU cGMP regulations, FDA and ICH guidance, technology transfer, process validation, and lifecycle management.
• Experience working with external CDMOs, including oversight of manufacturing campaigns and technical issue resolution.
• Working knowledge of statistical process monitoring, process characterization, and quality risk management tools.
• Experience interpreting manufacturing data, troubleshooting process issues, and implementing scientifically sound solutions.
• Excellent technical writing and documentation skills, including preparation of protocols, reports, investigations, and regulatory documentation.
• Strong interpersonal and organizational skills, with exceptional communication abilities.
• Ability to travel 20%-25% domestically and internationally.
• All positions have an essential job function to perform face-to-face work with colleagues and/or onsite in San Diego; no role is expected to be 100% remote.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Target base pay range: $150,000.00 - $195,000.00. Actual pay offered will depend on the candidate’s experience, education, skills, and location. The compensation package includes a combination of cash (base pay and short-term incentive) and long-term incentive compensation (company stock).