Associate Director, Analytical Development

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.
• Aid in preparation of submission sections related to DS and DP analytical package and structural characterization.
• Write technical reports on a variety of chemistry related subjects.
• Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.

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.
• Practice 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.
• Pioneered ability to manage multiple priorities in a fast-paced environment.
• Experience with Veeva/Quality Doc a plus.
• Able to travel 15-20% domestically and internationally.