Associate Director, Technical Operations

106800 Technical Operations

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.

This position reports to the Senior Director, Technical Operations and is responsible for the development, execution, and ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget & scope.

This individual leads external manufacturing partners and collaborates closely with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve development, regulatory, and commercialization milestones.

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I-III clinical development and commercial products.
• Lead the selection, qualification, governance, and performance management of CMOs, collaboration partners, and other external technical service providers, ensuring delivery against agreed scope, quality, timelines, and budget.
• Oversee chemical development of new drug candidates
• Review regulatory filings, specifications, change controls, and Master Batch records
• Provide technical oversight of CMOs responsible for developing, validating, transferring, and maintaining manufacturing and analytical methods for clinical and commercial production of APIs and finished dosage forms. Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP requirements and global regulatory expectations.
• Provide technical leadership and mentorship to colleagues and cross-functional project teams.
• Author/edit CMC sections of regulatory submissions as required
• Additional duties assigned as needed.

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8 years of progressive cGMP related CMC drug development or manufacturing experience required.
• Must show demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity.

• The ideal candidate will embody Travere's core values:
  Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Manufacturing experience with oral solid dosage forms.
• Advanced knowledge of process validation, technology transfer,…