Analytical Development - Sci III
Core
Develop, characterize, and scale-up bioprocesses for robust manufacture of viral vectors to deliver lifesaving therapies.
Role type
Senior IC analytical development scientist (gene therapy)
Builds
Viral vector assays and analytical methods for gene therapy products
Domain
Biopharmaceuticals / Gene Therapy / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry, Mass spectrometry, Biophysics, Physiochemistry, Analytical ultracentrifugation, Dynamic light scattering, Mass photometry, HPLC, SOP development, DOE design, Method transfer, Lab management
Preferred skills
Chemistry, Virology, cGMP knowledge, GLP knowledge
Technologies
Mass spectrometry, Analytical ultracentrifugation, Dynamic light scattering, Mass photometry, HPLC
Responsibilities
Plan, design, execute, and document analytical testing and method transfer activities; Mentor and coach junior team members; Independently develop and review SOPs, work instructions, test records, and test reports; Design and execute data-driven DOEs to support QbD assessment; Independently lead analytical method transfer from client to CMC Development and to QC; Independently analyze data, present results and conclusions to the team; Periodic client-facing role to walk through methodology and data analysis; Responsible for some lab management tasks
Seniority
Senior, hands-on IC
