Manufacturing Process Scientist
Core
Design, develop, and optimize sterile manufacturing processes for clinical and small-scale commercial injectable drug products (liquid, suspension, lyophilized) in partnership with clients.
Role type
Manufacturing Process Scientist (Process SME)
Builds
Sterile injectable drug products (liquid, suspension, lyophilized)
Domain
Pharmaceutical manufacturing / Contract manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterile pharmaceutical process development, Scale-up, Technology transfer, GMP compliance, Technical documentation (protocols, FMEA, GAP analyses), Risk assessment, Process optimization
Preferred skills
Analytical problem-solving, Multi-project management, Scientific literature review
Technologies
cGMP suites, FMEA tools, GAP analysis frameworks
Responsibilities
Define and optimize manufacturing processes based on QTPP, Lead technical investigations and risk assessments, Prepare technical documentation (manufacturing instructions, study protocols), Present scientific data to stakeholders and clients, Support audits and regulatory inspections, Collaborate with cross-functional teams (Manufacturing, Quality, Engineering)
Seniority
Mid-level, hands-on IC
