Senior Associate Scientist, Biologics III
About the role
About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary We have an opportunity for a Senior Associate Scientist, Biologics III to join our team. In this role, you will be responsible for testing samples, participating in method transfer and validation activities, drafting methods, and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. You will execute laboratory testing using techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology, kinetic binding assessment, and flow cytometry. This position requires attention to detail, adherence to regulatory compliance, and collaboration within a dynamic team environment.
Responsibilities
- Read and follow Standard Operating Procedures with attention to detail
- Train on 1-2 methods or techniques and perform ad hoc sample testing activities
- Participate with guidance in method transfer and validation activities under cGMP requirements
- Apply basic scientific and laboratory concepts and theories related to specific testing in the group
- Follow cGMP requirements for accurate and thorough documentation to meet regulatory compliance
- Draft technical documents such as methods, method forms, and result reports
- Perform peer review of laboratory notebooks, logbooks, and method forms
- Adhere to policies, processes, and procedures for operating laboratory equipment safely and compliantly
- Understand Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices
- Perform other duties as assigned
Requirements
- Bachelor’s Degree in Life Sciences or Physical Science with a minimum of 2 years relevant experience in department-specific techniques, OR Master’s