Associate Scientist

We are seeking a CW Associate Scientist to support technical transfer and lifecycle-management activities for commercial drug product fill-finish processes. The individual will support transfers between development and manufacturing sites and will work closely with Process Development, Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other cross-functional partners The role will emphasize preparation and review of technical transfer documentation, study protocols, reports, process assessments, product impact assessments, and regulatory-support documents. The candidate will also support process characterization and laboratory-based activities as needed The successful candidate will have a strong understanding of end-to-end drug product manufacturing, including formulation, mixing, hold operations, sterile filtration, filling, lyophilization, and product-contact systems. Time will be divided between supporting laboratory and process-development activities and developing clear, scientifically rigorous technical documentatio Responsibilities n Responsibiliti es Author, data-verify, and review technical transfer documents, study protocols, technical reports, product impact assessments, data summaries, and regulatory-support documentati on.Compile, analyze, and interpret development and manufacturing data to support technical transfer, process characterization, validation, and regulatory filin gs.Execute laboratory analytical testing, including viscosity, protein concentration, pH, osmolality, and other relevant product-quality measuremen ts.Execute laboratory experiments involving pipetting, formulation, mixing, filtration, sampling, and product-contact evaluatio ns.Provide technical support for drug product fill-finish processes, including formulation, mixing, filtration, and filling of vials, syringes, devices, and other parenteral presentatio ns.Assist with the development and characterization of drug product processes and transfer of technologies between development and commercial sterile fill-finish sit es.Support commercial drug product activities involving sterile processing, process characterization, technical transfer, validation, and lifecycle manageme nt.Evaluate site-to-site differences in equipment, materials, scale, process parameters, and manufacturing procedur es.Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other support functions to advance technical transfer and commercial manufacturing activiti es.Participate in global cross-functional teams and work effectively within a highly matrixed environme nt.Troubleshoot drug product processing technologies and equipment using data-driven analyses and visualizations to identify root causes and recommend solutio ns.Support product-contact, IV bag, compatibility, or administration-system studies, as nee Required Sk ee ORBachelor degree and 2 years of experien ce ORAssociate degree and 6 years of experien ce ORHigh school diploma / GED and 8 years of exper ience Preferred Skills Drug product fill-finish and technical transfer exp erienceStrong understanding of formulation, mixing, sterile filtration, filling, and transfer of parenteral drug product processes between development and commercial manufacturing sites.Technical writing and data interpr etationDemonstrated ability to author, data-verify, and review technical protocols, reports, impact assessments, transfer documents, and regulatory-support documen tation.Hands-on laboratory and analytical exp erienceExperience executing drug product experiments and analytical testing, including formulation, filtration, pipetting, pH, protein concentration, viscosity, and osm #J-18808-Ljbffr Crystal Equation Corporation