Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company focused on developing and delivering life-changing therapies for people living with rare diseases. The Associate Director, Technical Operations will oversee analytical operations for biologics products, including method development, validation, transfer, specifications, and reference standards. The role serves as an analytical subject matter expert and supports regulatory submissions, manufacturing compliance, and collaboration with internal teams and external CDMOs/CROs.
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
Skills
- B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required
- 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
- Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs
- 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
- 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
- M.S. degree preferred
Benefits
- Premium health, financial, work-life and well-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability insurance
- Retirement plans with employer match
- Generous paid time off
- Short-term incentive compensation
- Long-term incentive compensation in the form of company stock
Company Overview
Company H1B Sponsorship