Associate Director, Technical Operations – CMC Strategy

Travere Therapeutics

Associate Director leading CMC strategy for small molecule drug development at biopharmaceutical company. Collaborating with cross-functional teams to ensure alignment and timely drug supply.

Posted 6/25/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $150,000 - $195,000 per yearWebsite

ATS Keywords

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Hard Skills

cGMP manufacturingformulation developmentCMC developmentprocess validationtechnology transferregulatory submissionsrisk assessmentssmall molecule APIsoral solid dosage formsbiologics

Soft Skills

strategic leadershiptechnical oversightmentorshipcross-functional collaborationproblem resolutionproject managementcommunicationteam leadershiporganizational skillscompliance management

Tools & Technologies

Master Batch recordsvalidation documentschange controlsregulatory filingsINDsIMPDsNDAsrisk mitigation strategiesclinical operationssupply chain management

Industry Keywords

Life SciencesPharmaceutical SciencesChemical EngineeringcGMPUS FDA guidelinesEU regulationsICH guidelinesclinical developmentcommercializationthird-party manufacturers

About the role

Key responsibilities & impact

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
Managing CMOs to develop and maintain methods for clinical/commercial production of finished dosage forms
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

Requirements

What you’ll need

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

Benefits

Comp & perks

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
generous paid time off