Catalent
drug development and delivery
SeniorScientist,AnalyticalResearch&Development
“Senior Scientist, Analytical Research & Development at Catalent. Skills: Analytical Research & Development, method development, method validation, instrumental test methods, HPLC, UPLC, GC, MS, NMR. support the development and validation of analytical test methods. raw material evaluation”
What You'll Achieve.
advance product development, manufacturing, process validation, and new material qualifications in accordance with regulatory and quality standards; ensure right-first-time execution of departmental methods; audit and verify analytical results for accuracy and data integrity; maintain proper records in notebooks, reports, and logbooks in compliance with FDA, EPA, OSHA, and company regulations
Industry & Context.
Root Cause Analysis
100% on-site, VISION: Ability to read written documents and computer monitors, differentiate color, and maintain 20/30 vision with or without corrective lenses, Able to work extended or off-hours as required, Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds, No lifting greater than 44.09 pounds without assistance, Safely handle potent and teratogenic compounds
What They're Looking For.
Must Have
Doctorate in scientific field with 3-years’ experience in lab, 2 in GMP required, Master’s in scientific field with 5+yrs experience in lab, 3 in GMP required, Bachelor’s in scientific field with 10-yrs experience in lab, 8 in GMP required, Minimum of 5 years’ experience with identification or separation techniques such as HPLC, UPLC, GC, MS, NMR and experience with method development and or validation, Ability to read written documents and computer monitors, differentiate color, and maintain 20/30 vision with or without corrective lenses, Able to work extended or off-hours as required, Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds, No lifting greater than 44.09 pounds without assistance
What You'll Do.
support the development and validation of analytical test methods
raw material evaluation
testing of non-commercial materials to advance product development
and new material qualifications
Independently develop
and routinely execute instrumental test methods in support of Drug Substances and Drug Products
document results in accordance with cGMP and internal guidelines
and communicate findings through written and oral presentations
Serve as lead scientist for designated projects
Perform analysis of finished products
cleaning verification/validation samples
and support the Material Evaluation Process for new materials according to assigned specifications
and support analytical methods
and laboratory investigations using appropriate Root Cause Analysis
lead analytical method transfer activities as required
Ensure right-first-time execution of departmental methods
audit and verify analytical results for accuracy and data integrity
maintain proper records in notebooks
and logbooks in compliance with FDA
and company regulations
Safely handle potent and teratogenic compounds
and manage hazardous waste
support ordering and maintenance of laboratory materials and equipment
Contribute to continuous improvement by training colleagues
leading and coordinating personnel training
participating in inter-departmental teams
interfacing with management
self-scheduling assignments
and working flexible hours as required to support production and validation schedules
How You'll Work.
Team & Collaboration
cross-functional collaboration; Serve as lead scientist for designated projects, including direct client communications, participation in project team meetings and teleconferences; support of new product development in collaboration with customers and suppliers; participating in inter-departmental teams; interfacing with management
Communication Scope
communicate findings through written and oral presentations; direct client communications; participation in project team meetings and teleconferences
Process & Methodology
Serve as lead scientist for designated projects
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