Process Development Sr Scientist
Core
Lead analytical work for late-stage biologic product development, defining quality targets and managing method transfer to manufacturing.
Role type
Senior IC process development scientist (analytical chemistry/biologics)
Builds
Robust manufacturing processes for monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development for biologics, Mass spectrometry (intact mass, peptide mapping), HPLC/CE methods, Regulatory filing authoring, Method transfer and validation, Product quality attribute characterization
Preferred skills
Multispecific antibody expertise, Regulatory guideline knowledge, Contract manufacturing management, Cross-functional leadership
Technologies
Mass spectrometry, HPLC, CE, cIEF, CE-SDS
Responsibilities
Supervise analytical support for late-stage development, Define analytical target profiles (ATP), Manage activities at contract manufacturing sites, Author CMC sections in regulatory documents, Drive product characterization for comparability studies, Evaluate platform technologies for innovation
Seniority
Senior, hands-on IC with team lead responsibilities
