Process Scientist I
Core
Technical lead for technology transfer and manufacturing process support in a GMP environment, developing process understanding and ensuring compliance for biologics.
Role type
Process Scientist I (Manufacturing Science and Technology)
Builds
Biologics manufacturing processes and technology transfers
Domain
Life Sciences / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP-regulated manufacturing knowledge, process development support, risk assessment, technical documentation authoring, data analysis, deviation investigation, root cause analysis
Preferred skills
Master's degree or PhD, advanced analytical skills
Technologies
cGMP systems, batch record systems
Responsibilities
Serve as technical lead for technology transfer and manufacturing process support; Develop process understanding and perform risk assessments; Author and review process descriptions, batch records, and change controls; Monitor manufacturing performance and analyze process data; Support deviation investigations and root cause analysis; Represent team on customer-facing projects and audits; Support lot release activities.
Seniority
Individual Contributor, Entry to Mid-level