Associate Director, Technical Operations

Travere Therapeutics; San Diego (CA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health plan

401(k) with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior CMC leader to develop and oversee the CMC strategy for a diverse portfolio of small molecules in development and through commercialization. You will manage external CMOs, ensure compliance, and drive regulatory-ready chemistry, manufacturing, and controls documentation.

The role collaborates with Quality, Regulatory, Clinical, Supply Chain and Program Management, shaping risk‑based approaches to deliver milestones on time and within budget.

Qualifications

• Bachelor’s degree in a related field is required.
• 8 years of progressive cGMP-related CMC drug development or manufacturing experience.
• Leadership experience in CMC across multiple areas and small molecules/peptides/biologics desirable.

Responsibilities

• Develop, execute, and oversee the CMC strategy for diverse portfolio.
• Lead external manufacturing partners and CMOs to meet scope, quality, timelines, and budget.
• Oversee chemical development, regulatory filings, specifications, and master batch records.
• Provide technical oversight of CMOs for API finished dosage forms.
• Support regulatory inspections and audits; ensure global cGMP compliance.
• Provide mentorship to cross‑functional teams; contribute to regulatory submissions.

Skills

CMC leadership

Technology transfer

CMO management

cGMP knowledge

Regulatory collaboration

Project leadership

Education

Bachelor’s degree in Process/Chemical Engineering or Life Sciences

Tools

Process validation

Scale-up

Analytical method development

Job description

Department: 106800 Technical Operations Location: 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.

Position Summary:

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.

Responsibilities:

• 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.

Education/Experience Requirements:

• 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.

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
• 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 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.
• Ability to travel 10% domestically and internationally All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people‑centric, and pay‑for‑performance organization.

Benefits:

• Our benefits include 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 and generous paid time off.

Compensation:

Our competitive compensation package includes a combination of both cash compensation (base pay and short‑term incentive) and long‑term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range: $150,000.00 - $195,000.00 *This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

For more information, visit travere.com.