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:
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. This role is a critical contributor within Technical Operations (CMC) and broadly supports the product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products.
This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will bring substantial experience in small molecule API development and manufacturing, appropriate for advancing a late-stage development asset to commercial readiness.
Responsibilities:
Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at Travere CDMOs.
Review and approve manufacturing-related documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
Verify suitability, qualification, and validation status of processes at CDMOs and other external laboratories.
Provide technical support for GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
Collaborate with internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products.
Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs.
Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations applicable to pharmaceutical development and manufacturing.
Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives.
Additional duties assigned as needed.
Education/Experience Requirements:
B.S. degree in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related Life Sciences discipline required. M.S. or Ph.D degree preferred. Equivalent combination of education and applicable job experience may be considered.
8+ years of relevant experience required with emphasis on late-phase clinical development, scale-up, and commercialization.
Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule APIs for solid oral dosage formulations.
Demonstrated experience managing and providing technical oversight of CDMOs and contract testing labs, preferably across global manufacturing and testing sites.
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.
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.
Successful record of creating and managing complex project plans, timelines, budgets, and development of risk mitigation strategies.
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.
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.
Travere is an EEO/AA/Veteran/Disability Employer
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,... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
