Senior Scientist, Engineering- Lab Start-Up and Commercialization
Core
Lead laboratory start-up and operations for biologics conjugation processes, establishing scale-down models to support process characterization and regulatory filings.
Role type
Senior Scientist, Laboratory Operations & Commercialization
Builds
Lab-scale conjugation systems, qualified scale-down models, and operational processes for biologics pipelines.
Domain
Biologics / Bioconjugation / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Antibody Drug Conjugates (ADC), Bioconjugation, Bioreactors, Capital Planning, cGMP Regulations, Chromatographic Techniques, Design of Experiments (DOE), Good Manufacturing Practices (GMP), Laboratory Operations, Process Design, Process Optimization, Process Scale Up, Project Management, Root Cause Investigations
Preferred skills
Conjugation Chemistry, Potent Compound Handling, Pilot/Commercial Scale Manufacturing, Process Validation, CMMS Software, Data Analytics Software, Capital Project Management
Technologies
SAP, Procal, Maximo, QlikSense, Spotfire
Responsibilities
Lead daily lab operations including scheduling, training, and inventory management; Lead capital asset startup, maintenance, and troubleshooting; Ensure compliance with safety, environmental, and regulatory requirements; Establish lab scale-down models for process characterization; Engage cross-functional teams to drive business objectives and operational efficiency.
Seniority
Senior, hands-on IC with leadership responsibilities
