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Associate Scientist II
Job Description
I. Position Overview
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 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 cell 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
Knowledge/Skills Requirements:
Has basic knowledge of the principles and concepts of a discipline (e.G., Biology, Chemistry, Biochemistry).
Excellent written and verbal communications skills with internal customers, colleagues, and supervisor
Well organized with ability to multitask and be flexible with daily work schedule
Ability to work effectively under pressure to meet deadlines
Ability to pay attention to detail and exhibit critical thinking
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