Associate Director, Technical Operations

Travere Therapeutics

. Develop, execute, and provide ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development .

Posted 9/29/2026full-timeSan Diego • California • United StatesSenior💰 $150,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC strategy development and execution for small molecules, with a strong focus on cGMP compliance, technology transfer, and cross-functional collaboration. Proven leadership in managing external manufacturing partners and overseeing drug development processes from Phase I to commercialization.

Highest-signal resume keywords

CMC Strategy DevelopmentCGMP ComplianceTechnology TransferDrug Development ExperienceLeadership in CMC

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ValidationManufacturing ControlsAnalytical Method DevelopmentRegulatory SubmissionsChemical DevelopmentScale-Up ActivitiesRisk MitigationQuality OversightProject ManagementSmall Molecule Drug Development

Soft Skills

Strong Interpersonal SkillsExcellent Communication SkillsOrganizational SkillsDecision-Making SkillsAttention to Detail

Industry Keywords

CGMP RequirementsRegulatory AffairsClinical DevelopmentExternal Manufacturing PartnersMaster Batch RecordsPhase-Appropriate cGMPCollaboration PartnersAPIsOral Solid Dosage FormsBiologics

About the role

Key responsibilities & impact

Develop, execute, and provide ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development
Ensure test articles and study drugs are developed and manufactured on time, within budget, and within scope
Lead external manufacturing partners
Collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management
Identify and mitigate CMC risks
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 selection, qualification, governance, and performance management of CMOs, collaboration partners, and external technical service providers
Oversee chemical development of new drug candidates
Review regulatory filings, specifications, change controls, and Master Batch Records
Provide technical oversight of CMOs developing, validating, transferring, and maintaining manufacturing and analytical methods for APIs and finished dosage forms
Support regulatory inspections, partner audits, and ongoing compliance with cGMP requirements and global regulatory expectations
Provide technical leadership and mentorship to colleagues and cross-functional project teams
Author and edit CMC sections of regulatory submissions as required
Perform additional duties as assigned

Requirements

What you’ll need

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
Demonstrated leadership experience in CMC, preferably in more than one related CMC area
Drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity
Manufacturing experience with oral solid dosage forms
Advanced knowledge of process validation, technology transfer, manufacturing controls, and phase-appropriate cGMP requirements
Ability to adapt to modifications and changes to project plans
Strong interpersonal and organizational skills
Excellent verbal and written communication skills
Excellent decision-making and collaboration skills
Strong attention to detail
Ability to travel 10% domestically and internationally
Ability to perform face-to-face work with colleagues and/or onsite in San Diego

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 benefits
Retirement plans with employer match
Generous paid time off
Short-term incentive
Long-term incentive compensation (company stock)