Process Development Senior Associate
Core
Develop, characterize, and support commercialization of drug product manufacturing processes for late-stage biologic programs (monoclonal antibodies, BiTEs, fusion proteins).
Role type
Senior IC process development scientist (biologics)
Builds
Late-stage drug product formulations and fill/finish processes
Domain
Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
formulation development, process characterization, ultrafiltration/diafiltration, filtration, mixing, analytical testing (SEC, CEX, HIAC, MFI), statistical analysis (SAS, JMP, Minitab), data visualization (TIBCO Spotfire, MS Smartsheet), protocol authoring
Preferred skills
process development, technology transfers, equipment design and implementation, physical/chemical stability of proteins, programming (Python, R, MATLAB), SQL, Tableau, D3js
Technologies
TIBCO Spotfire, MS Smartsheet, JMP, SAS, Minitab, Python, R, MATLAB, SQL, Tableau, D3js
Responsibilities
Plan and design formulation and process development studies; execute and document laboratory studies (UF/DF, filtration, freeze-thaw, stability); evaluate product and process performance via analytical testing; build data and analytics solutions; perform statistical data analysis; author/review technical protocols and reports; participate in team meetings
Seniority
Senior, hands-on IC
