Scientist, Drug Product Development
Core
Develop world-class patient-centric biopharmaceutical drug products (mAbs, bispecific mAbs, ADCs, small molecules) through sterile formulation and process development.
Role type
Scientist/Senior Scientist in Drug Product Development (Formulation & Process)
Builds
Clinical and commercial drug products for vaccines and medicines
Domain
Biopharmaceuticals / Protein Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (drug product manufacturing)
Required skills
Laboratory experimentation, biophysical techniques, stability studies, formulation robustness, process development (mixing, sterile-filtration, filling, lyophilization), tech transfer, scale-up, regulatory documentation authoring
Preferred skills
Protein chemistry/structure, drug delivery/device development, fill-finish manufacturing, in-use/administration compatibility studies, biophysical characterization (SLS, DLS, DSC, MFI, HIAC)
Technologies
SLS, DLS, DSC, MFI, HIAC
Responsibilities
Design and execute study protocols; troubleshoot experimental processes; author development protocols, technical reports, and regulatory sections (IND, IMPD, BLA, MAA); maintain electronic laboratory records
Seniority
Mid-level IC (2+ years exp with Bachelor's or 1+ years with Master's)
