Senior Engineer
Core
Senior Engineer leading late-stage drug product formulation, fill/finish process development, and lifecycle management for biological modalities (large molecule, RNA, virus) using advanced AI and in silico modeling.
Role type
Senior IC process development engineer (biologics/pharmaceuticals)
Builds
Biologics drug products and manufacturing processes for commercialization
Domain
Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
formulation development, aseptic processing, fill/finish process design, first principles modeling, statistical analysis, data acquisition, root cause analysis, validation planning, regulatory compliance (FDA/EU), risk assessment, CAPA implementation, cross-functional project leadership
Preferred skills
new product development, automated visual inspection, statistical process control (SPC), experimental design, digital process control, data science, coding, deep learning, machine learning, robotics, machine vision, optics, additive manufacturing, cGMP manufacturing environment, technical transfers to global sites
Technologies
generative AI, large language models (LLMs), in silico modeling, statistical analysis software, digital process control systems, robotics, machine vision, optics, additive manufacturing
Responsibilities
Plan, design, execute, and document laboratory studies for formulation and fill/finish; Apply engineering skills and modeling to solve technical problems; Perform data analysis using advanced statistical techniques; Leverage AI and in silico modeling to accelerate R&D; Provide support to manufacturing operations via troubleshooting and process capability analysis; Author regulatory documents and protocols for IND and marketing applications; Conduct risk assessments and implement CAPA; Lead cross-site teams and develop validation plans
Seniority
Senior, hands-on IC with project leadership
