Associate Scientist II, Injectable Drug Product Development
Core
Design and execute formulation and process development studies for clinical biologic candidates, including physico-chemical characterization and stability testing.
Role type
Associate Scientist II, Injectable Drug Product Development
Builds
Clinical biologic drug products
Domain
Pharmaceutical/Biotechnology, Protein/Peptide Biochemistry
Required skills
Protein/peptide biochemistry, Protein formulation, Stability testing, Formulation development, Process development, Analytical chemistry, Biophysical characterization, Study design, Experimental execution, Technical reporting
Preferred skills
Process scale-up, Tech transfer, Manufacturing experience, Sub-visible particle testing, Regulatory guidelines knowledge, Electronic lab notebook (ELN) usage, Laboratory instrumentation maintenance
Technologies
iCE/Maurice, H/UPLC (IEX, SEC), DLS, CD, DSC, AUC, NanoTemper, MS Office, ELN, EndNote, e-logbooks
Responsibilities
Design and execute formulation and process development studies for clinical biologic candidates; Execute drug development studies including physico-chemical characterization and stability studies; Characterize conformational and colloidal stability using industry standard methodology; Maintain organized records and use team tools to keep multiple assignments on track; Assist in the preparation of internal technical reports on executed studies; Participate in cross-functional development teams
Seniority
Mid-level, hands-on IC
