Process Development Scientist

Overview In this role you will drive the development of current and new manufacturing processes for HPAPI APIs in a GMP environment. You will work within the Process Development team in Riverview, MI to design, test, and scale-up synthetic pathways and analytical methods. You will collaborate with clients and internal teams to ensure regulatory and quality requirements are met while advancing process transfer and production readiness. This position offers hands-on work with potent compounds and opportunities to shape HPAPI process strategies at scale. ResponsibilitiesDevelop and manage process development for current and new synthetic pathways, including routine analytical monitoring (HPLC, NMR, XRPD, GC-HS, KF)Scale-up preparative HPLC purification and lyophilization of intermediates and final productsMaintain client communications and ensure requirements are metSupport production of new HP APIs and ensure material availability for tasksEnsure shipments meet regulatory requirements (FDA, EPA, OSHA) and cGMP documentationWrite progress reports and provide technical support for API production and process developmentDocument processes according to cGMP, keep QA/QC updated on project needsParticipate in development, training, and transfer of new processes into the plantMaintain accurate inventories, notebooks, logs, and regulatory-compliant recordsProvide technical support to operators, engineering, and quality control teamsPrepare reports for management and clients Key requirementsPhD in Organic or Medicinal Chemistry with up to 4 years of experience, OR MS with up to 8 years, OR BS with up to 12 yearsStrong knowledge of organic chemistry and chemical safetyFamiliarity with cGMP, plant safety, and EPA requirementsExcellent organizational, planning, and communication skillsAbility to direct projects involving high potent APIsExcellent organizational and planning skillsStrong written, verbal, and interpersonal communicationSelf-motivated, creative, and independentHPLCNMRXRPD