Associate Director, Technical Operations Quality Control

Travere • San Diego, CA

6d • Remote

About The Position

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 QC is responsible for managing Quality Control activities at Travere in compliance with GMP and international regulatory standards. The candidate provides technical leadership and scientific decision-making for QC control strategies, and must have extensive knowledge of FDA, ICH and EU regulatory requirements with the ability to work effectively in a virtual environment. This position collaborates closely with colleagues in Analytical, CMC, Quality, and Regulatory groups, supporting the corporate goals for clinical development to commercialization of a small molecule drug product for a rare disease indication.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or related Life Sciences discipline required.
• Master’s degree preferred.
• Equivalent combination of education and applicable job experience may be considered
• 8+ years of relevant experience in analytical operations, analytical development, or quality control of biologics required.
• Experience in late-stage drug development preferred
• Direct knowledge of Dissolution, HPLC, GC, MS, NMR, IR, UV and other relevant analytical methods
• Broad knowledge and experience within the GMP environment and regulatory affairs

Nice To Haves

• 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
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong professional experience in a similar role within the biotech or pharmaceutical industry, preferably small molecule pharmaceuticals and biologics
• Practive team player with strong interpersonal and organizational skills
• Able to work both independently and in a team environment
• Strong verbal and written communication skills
• Excellent decision-making and collaboration skills with strong attention to detail
• Proven ability to manage multiple priorities in a fast-paced environment
• Experience with Veeva/Quality Doc a plus

Responsibilities

• Coordinate and lead Quality Control (QC) activities in support of drug substance and drug product manufacturing.
• Oversee specification development, batch release, and stability program of drug substance and drug product at Contract Manufacturing Organizations (CMOs).
• Provide scientific and technical support to internal and external groups to ensure that products are tested and released in compliance with all applicable regulations.
• Provide QC oversight of stability program, including forced degradation and photostability studies from designing the studies to approving the protocols, data review, trend analysis and preparation of internal stability reports in support of shelf-life determination.
• Collaborate with Analytical Development team to provide support for method transfer activities.
• Collaborate with Regulatory CMC group to support preparation and QC of regulatory submissions and variations.
• Support internal manufacturing team’s comparability assessments for process changes.
• Provide guidance and work with external vendors during OOS, OOT, atypical result investigations and deviations, ensuring final reports are scientifically sound, risk-based, and appropriate CAPAs are implemented, where applicable.
• Serves as an SME in support of Travere’s Quality Assurance (QA) PAI readiness activities and Vendor audits.
• Additional duties assigned as needed.

Benefits

• 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
• generous paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Manager