Analytical Technical Steward-Small Molecule

Role: Analytical Technical Steward in API External Manufacturing Quality Control, focused on ensuring the integrity and compliance of analytical testing for small molecule APIs. Responsibilities: perform technical review and release of data from contract manufacturers, lead investigations of out-of-specification results, develop testing protocols, support method validation, transfer, and improvements, oversee reference standard evaluations, and participate in audits and continuous improvement initiatives. Requirements: Bachelor's in Chemistry, Biochemistry, or Pharmacy; 5+ years in GMP pharmaceutical labs; proficiency in chromatography (HPLC, GC), spectroscopy, and compendial tests; strong understanding of data integrity and compliance standards including ALCOA++. HighValue: Small molecule APIs, GMP environment, analytical method validation, data integrity, contract manufacturing support, global collaboration, and potential travel (~20%). WorkSetup: Day shift with some overseas travel.