Senior Scientist, Engineering II
Core
Lead late-stage development, scale-up, validation, and commercialization of oral solid dosage products, applying scientific and engineering principles to establish robust manufacturing processes and control strategies.
Role type
Senior Scientist, Engineering II (Process Development & Scale-Up)
Builds
Oral solid dosage pharmaceutical products for commercialization
Domain
Pharmaceutical manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing scale-up and validation)
Required skills
Oral solid dosage form development, manufacturing scale-up (pilot to commercial), technology transfer, process characterization, PPQ and validation, Design of Experiments (DoE), statistical approaches, Quality by Design (QbD), risk assessment, control strategy development, regulatory CMC documentation
Preferred skills
None explicitly stated as preferred, only required experience levels
Technologies
None explicitly listed (DoE and statistical tools mentioned as methods)
Responsibilities
Resolve key project hurdles using technical expertise, lead scale-up of oral solid dosage processes, develop and execute technology transfer strategies, apply experimental design and modeling tools, establish process control strategies and critical parameters, lead process characterization and validation, author regulatory CMC documentation, incorporate new scientific literature, collaborate with cross-functional teams
Seniority
Senior, hands-on IC with significant leadership in project execution
