Associate Director, Technical Operations (Analytical Development-Biologics

Position: Associate Director, Technical Operations (Analytical Development-Biologics)
Location: Northern

## Associate Director, Technical Operations (Analytical Development-Biologics)
Apply locations:
San Diego:
USA
- Remote time type:
Full time posted on:
Posted Todayjob requisition :
R-100922

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 is responsible for the analytical operations of a biologics product and serves as an analytical subject matter expert for Travere.  This position is responsible for analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards.  The candidate must have extensive knowledge of FDA, ICH and EU regulatory requirements and have 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 a biologics drug product for a rare disease indication.
** Responsibilities**:
* Manage and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.
* Oversee specification setting of drug substance and drug product at CDMOs/CROs.
* Author/review analytical method validation protocol/report, method transfer protocol/report and SOPs.
* Manage reference standard program for drug substance and drug product.
* Review controlled documents such as batch records and CoAs.
* Assist in OOS and OOT investigations. Perform root cause analyses and recommend corrective actions.
* Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.
* Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
* Additional duties assigned as needed.
** Education/Experience Requirements:
*** B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered.
* 8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.
* Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical methods.

Experience with PEGylated and/or lyophilized products is a plus.
* Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.
** 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.
* Maintain up-to-date knowledge of US and EU GMPs, USP, Ph. Eur,…