HPLC Specialist, Scientist II, Biologics Drug Product Development
Core
Lead HPLC/UPLC characterization and drug product process development for biologic therapeutics from preclinical through clinical proof of concept.
Role type
Senior IC analytical scientist (HPLC specialist)
Builds
Biologic drug product formulations and manufacturing processes
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC method development and troubleshooting, formulation development for biologics, technical writing for regulatory submissions, training others on analytical instrumentation, project management, statistical data analysis
Preferred skills
Empower software proficiency, experience with solid oral dosage forms or parenteral delivery systems
Technologies
Empower, HPLC, UPLC, ELN
Responsibilities
Serve as SME for HPLC/UPLC characterization of biologics, lead advanced troubleshooting of HPLC/UPLC instrumentation, develop and deliver HPLC training curricula, independently lead drug product process development studies, generate scientific data packages for regulatory submissions, analyze and document experimental data in electronic lab notebooks
Seniority
Senior, hands-on IC