Associate Director, Analytical Development
Director | Analytical R&D
Greater Bay Area
$180,000 - $220,000 + excellent bonus/benefits
Duties and Responsibilities:
Able to facilitate, analyze and interpret the data from experiment results
Ensure protocols are in compliance with company policies, sch as ICH, GMP, USP and FDA regulations
Strong communication, organization, and multitasking skills are needed to lead
Install new equipment, processes, and methods for the solution of technical problems
Will work and manage in-house and outsourced lab activities.
Focus on multiple compounds within their pipeline (approaching phase III)
Operate wet chemistry instruments such as HPLC, LC-MS, FTIR, KF, UV/Vis, Etc.
Qualifications:
Have experience in method developments(ideally from scratch)
Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs)
Experience coaching and mentoring junior scientists(highly coveted)
M.S or Ph.D. in Chemistry or a related scientific field with ideally 5-7 years of industry experience
Experience authoring CMC sections for IND, and NDA is highly sought after