Senior Scientist, Analytical Development

Role: Senior analytical development scientist leading projects to support R&D, tech transfer, and commercialization of biopharmaceutical drug substances and products. Responsibilities: design, plan, and execute analytical methods for preclinical through commercial stages; oversee batch testing, release, and regulatory documentation; manage cross-functional teams and external contractors; support process chemistry and formulation development; contribute to CMC regulatory submissions; supervise laboratory personnel and ensure GMP compliance; drive innovation in analytical techniques; build internal and external collaborations. Requirements: BS/BA in Chemistry with 12+ years, MS/MA with 10+ years, or PhD with 4+ years in pharmaceutical/analytical chemistry; deep expertise in analytical method development, transfer, and validation; strong knowledge of cGMP, process chemistry, and formulation; excellent communication, project management, and leadership skills; proficiency with laboratory equipment and software. Preferred: experience in biopharma API/drug product development, regulatory submissions, and cross-functional collaboration. High-Value: involvement in biopharma analytical development supporting drug substances and products through preclinical to commercialization, with emphasis on GMP and regulatory standards, and leadership in complex projects.