Position Summary:
The Associate Director of Analytical Development, Technical Operations serves as analytical subject matter expert for Travere and is responsible for analytical method development, validation and transfer in compliance with cGMP and international regulatory standards for drug substances and drug products generated by external laboratories and manufacturers. The candidate must have extensive knowledge of FDA, ICH and EU regulatory requirements and the ability to work effectively in a virtual environment.
This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of drug substances and drug products for rare disease indications.
Responsibilities:
- Provide technical leadership and independently manage/oversee method development, validation and transfer at CRO/CMO laboratories for small molecule products.
- Oversee specification setting of drug substance and drug product at CDMOs/CROs
- Perform technical reviews and approval of analytical method validation protocol/report and method transfer protocol/report and SOPs as well as experimental reports.
- Manage development activities such as IPC and release testing.
- Manage research activities such as impurity characterization.
- Provide scientific and technical guidance and support on internal and external project teams.
- Lead in troubleshooting OOS and OOT root causes. Perform evaluation and provide corrective actions when necessary.
- Assist in preparation of submission sections related to DS and DP analytical package and structural characterization.
- Write technical reports on a variety of chemistry related topics.
- Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
- Maintain up-to-date knowledge of US and EU GMPs, USP, Ph. Eur, and ICH guidelines as applicable to cGMP manufacturing and control of API’s and drug products.
- Additional duties assigned as needed.
Education/Experience Requirements:
- B.S. in Chemistry, Biochemistry, or related Life Sciences discipline required. Equivalent combination of education and applicable job experience may be considered
- 8+ years of extensive analytical development, validation and transfer background in Biotech or Pharmaceutical industry with experience reviewing analytical data and managing analytical development activities from external CRO/CMOs
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution and other relevant analytical methods
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 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 15-20% 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
