Scientist II, Biologics Drug Product Development
Core
Lead drug product development studies for biologic therapeutics (antibodies, ADCs, multispecifics) focusing on formulation, characterization, and manufacturing process support.
Role type
Scientist II, Biologics Drug Product Development (HPLC/UPLC SME)
Builds
Drug product formulations and manufacturing processes for clinical-stage biologic therapeutics
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics formulation development, HPLC/UPLC method development and troubleshooting, protein characterization (SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS), stability assessment, regulatory documentation (IND/NDA/BLA), Empower software proficiency, cross-functional collaboration
Preferred skills
Design of Experiments (DoE), IND/NDA/BLA filing support, scientific publications/patents, automation and data digitalization
Technologies
Empower, HPLC, UPLC, SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE
Responsibilities
Lead formulation screening and in-use studies for clinical support; Generate scientific data and documentation for regulatory submissions; Serve as primary technical resource for HPLC/UPLC systems including maintenance and troubleshooting; Develop and deliver HPLC training curricula and SOPs; Analyze and document experimental data in electronic lab notebooks (ELN); Present scientific findings to stakeholders and author technical reports
Seniority
Mid-Senior, hands-on IC
