Associate Director, Technical Operations (Analytical Development-Biologics)

Travere Therapeutics • San Diego, CA

2d • $150,000 - $195,000 • 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.

Requirements

• B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required.
• 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.
• Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.
• 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.

Nice To Haves

• M.S. degree preferred.
• Equivalent combination of education and applicable job experience may be considered.
• Experience with PEGylated and/or lyophilized products is a plus.
• 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.

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.

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
• company stock

What This Job Offers

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