Description:
Associate Scientist II is primarily responsible for testing samples, drafting methods and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies.
In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the following techniques as required:
- Mammalian cell culture
- Sterile technique
- In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay, etc.)
- ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD)
- Molecular biology (e.g., qPCR, PCR, etc.)
- Kinetic binding assessment (e.g., BLI or SPR)
- Flow cytometry
- Other technologies/methodologies as required by management
II. Essential Functions
- Reads and follows Standard Operating procedures with attention to details
- Successfully trains on 1-2 methods and/or techniques mentioned above and performs adhoc sample testing activities under cGMP as required
- Applies basic scientific and laboratory concepts and theories related to specific testing in the group
- Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance. Supports drafting of simple methods, method forms and result reports.
- Adheres to policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner
- Understands the Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices
- All other duties as assigned
III. Position Requirements
Education And Experience
- Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required