Principal Scientist, MS&T
Core
Principal subject matter expert and process owner for end-to-end manufacturing of liquids and lyophilized parenteral products, ensuring process transfer, optimization, and daily support to satisfy business plans.
Role type
Principal Scientist, Manufacturing Science & Technology (MS&T)
Builds
Liquid and lyophilized parenteral products (biologics/protein therapeutics)
Domain
Pharmaceutical manufacturing / Biologics
Required skills
Technical transfer planning, Process validation (cGMP), Design of Experiments (DoE), Process Risk Assessment (FMEA), Project management, Cross-functional team leadership, Equipment automation integration, CMC submission authoring, Mentoring junior scientists
Preferred skills
Parenteral manufacturing of protein therapeutics, Industrial parenteral formulation and filling expertise, Spanish fluency
Technologies
cGMP, FMEA, DoE, CMC, Automation systems
Responsibilities
Lead technology transfer projects from R&D to manufacturing, Execute process validation and optimization, Perform Design of Experiments and risk assessments, Author process sections for CMC regulatory submissions, Mentor and develop junior scientists, Partner with engineering and maintenance to ensure equipment capability, Represent the site in Technology Transfer Teams
Seniority
Principal, hands-on IC with strategic decision-making authority