Scientist II Process Development - Downstream
Core
Plan, execute, and document laboratory and tech transfer activities for viral vector process establishment, pilot, and transfer into cGMP manufacturing.
Role type
Mid-level IC downstream process development scientist
Builds
Viral vector purification processes for gene therapy clients
Domain
Biopharmaceutical manufacturing / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chromatography (affinity, anion exchange), Filtration (TFF, sterile, depth), Viral clearance, DOE, Scale-up/down, cGMP compliance, Technical writing
Preferred skills
AKTA systems, Unicorn software, Mammalian/insect cell culture expertise
Technologies
AKTA chromatography systems, Unicorn software
Responsibilities
Plan and execute bench and pilot scale process development activities; Serve as SME for viral vector downstream execution; Prepare and modify development plans, batch records, SOPs, and protocols; Support analytical testing for process characterization; Identify technical gaps and facility fit challenges for new clients/processes.
Seniority
Mid-level, hands-on IC
