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.
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.
Education/Experience 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
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
- 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
- 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
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:
*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.
