Lead Scientist, Purification Development
Core
Lead scientific process development and characterization for downstream manufacturing of recombinant therapeutic proteins.
Role type
Lead Scientist, Purification Development (Senior IC)
Builds
Downstream manufacturing processes for novel therapeutic proteins
Domain
Life Sciences / Biopharmaceuticals / Protein Purification
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
protein purification, process characterization, study planning, technical supervision, chromatography (Affinity, Mixed-Mode, Ion Exchange), ultrafiltration/diafiltration (UF/DF), viral reduction studies, risk assessments (FMEA), scale-down model qualification, Design of Experiments (DoE), resin reuse/lifetime studies, cGMP/BLA requirements, technical writing, problem-solving
Preferred skills
Process Validation, statistical software (JMP) for DoE data analysis, regulatory submission support
Technologies
ÄKTA, UNICORN
Responsibilities
Lead and oversee Process Development, Process Characterization, and/or Viral Clearance activities; Drive small-scale model studies including FMEA, scale-down qualification, DoE, and resin studies; Lead and support purification activities using chromatography and UF/DF; Train and mentor junior scientists; Prepare and review protocols, reports, SOPs, and technical documentation; Act as project representative for internal and external communication; Provide scientific support for manufacturing operations and technology transfer
Seniority
Senior, hands-on IC with mentorship responsibilities