Associate Director, Technical Operations (Analytical Development-Biologics)

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.
• Auxiliary 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.

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, and ICH guidelines as applicable to cGMP manufacturing and control of drug substance and drug product.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Proven ability to create and manage complex project plans, timelines, budgets, and critical path tasks.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Ability to travel 10-20% domestically and internationally.