Associate Director, Technical Operations

Travere Therapeutics; Columbus (OH); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego (hybrid) seeks a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development and manufacturing. You will oversee external CMOs, coordinate with Quality, Regulatory Affairs, Clinical, and Supply Chain, and drive risk mitigation to achieve milestones.

The role requires 8+ years in cGMP CMC drug development or manufacturing, strong leadership, and experience with small molecules, peptides, or biologics.

Qualifications

• 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.

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.

Skills

Leadership

Communication

Teamwork

CMC knowledge

cGMP

CMO management

Project management

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

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 will accept applications on an ongoing basis until a candidate is selected for the position.

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

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.