Associate Scientist

Summary

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

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

ded
Required Sk

• ills
  Master degr
• 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