Director, Technical Operations

Department:

106800 Technical Operations

Location:

San Diego

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 Director, Technical Operations- Drug Product- Late Phase/Commercialization, is responsible for drug product manufacturing, scale up, validation, and commercialization of a biologics product. The successful candidate enjoys managing external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, and Supply Chain. This position is a key CMC contributor for the commercialization of a biologics drug product for a rare disease indication.

Responsibilities:

• Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of drug product manufacture of a biological product at Travere's CDMOs.
• Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
• Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
• Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Collaborate on CMC development and commercialization of drug product with internal and external project teams.
• Author and review technical documents and regulatory filings, including INDs, IMPDs, and BLAs.
• Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
• Review project scope and ensure that contractual obligations of CDMOs meet quality standards and timelines.

Education/Experience Requirements:

• M.S. or Ph.D. degree in Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or other related discipline. Equivalent combination of education and applicable job experience may be considered.
• Minimum 8 years of relevant experience including biologics drug product manufacturing with a focus on scale-up, late phase clinical development, and commercialization.
• Manufacturing experience with lyophilization and aseptic processes are a must; combination drug product development experience a plus.
• Expert knowledge in process characterization studies, PPQ, and commercialization for parenteral protein products.
• Skilled in preparation of CMC modules of regulatory filings such as INDs, IMPDs, and BLAs.
• Extensive experience managing global CDMOs and/or third-party manufacturers and testing labs.
• Broad knowledge and experience with phase-appropriate cGMP requirements and US, EU, and ICH guidelines.

Additional Skills/Experience:

• Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development and commercialization.
• Successful record of creating and managing complex project plans, timelines, and 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.

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:

$181,000.00 - $235,000.00

• 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 accommodations@travere.com. 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.