Associate Director, Technical Operations CMC Strategy

Position Summary

The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution 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 will collaborate closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities, ensuring timely resolution of technical issues across Phase I–III clinical and commercial products.
• Oversee formulation development of current approved drugs and new drug candidates.
• Manage and provide technical oversight of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs).
• Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and commercial milestones.
• Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports.
• Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions.
• Partner closely with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals.
• Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements.
• Provide technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams.
• Support launch readiness and commercialization planning to ensure reliable product supply.

Education/Experience Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required.
• 8+ years of relevant experience in cGMP related CMC drug development and manufacturing with emphasis on late-phase clinical development, scale-up, and commercialization.
• Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage form programs.
• 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.
• Extensive experience managing global CMOs, third-party manufacturers, and testing labs.
• Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines.
• Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs.
• Manufacturing experience with oral solid dosage forms.
• Expert knowledge in process validation and technology transfer procedures.

Additional Skills/Experience

• 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.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
• 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.