Manufacturing Sciences, Process Scientist II
Core
Design, develop, and optimize sterile manufacturing processes for clinical and commercial injectable drug products.
Role type
Process Scientist II (Pharmaceutical Development)
Builds
Sterile injectable drug products (liquid and lyophilized formulations)
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterile manufacturing process design, scale-up, technology transfer, risk assessment, FMEA, GAP analysis, technical documentation, cross-functional collaboration, regulatory compliance (cGMP/GMP), client partnership
Preferred skills
None stated
Technologies
None stated
Responsibilities
Define and optimize manufacturing processes for sterile injectable products based on QTPP; Prepare and review technical documentation including manufacturing instructions, study protocols, and FMEA; Drive technical execution of process development, scale-up, and technology transfer; Lead technical investigations and risk assessments; Collaborate with Manufacturing, Quality, and Engineering teams; Present scientific data and recommendations to stakeholders and clients; Support audits and regulatory inspections.
