Associate Scientist II – BioChemical Analysis

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 Therapeutics, will execute laboratory testing using the following techniques as required:

• Compendial assays, (i.e., appearance. pH, Osmolality, Particulate measurements, Viscosity etc.)
• Karl Fischer
• UV-Vis
• HPLC/UPLC techniques/methods (e.g., SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis etc.)
• Aggregation techniques such as MFI, AUC, SEC-MALS
• Capillary and Gel Electrophoresis (e.g., CE-SDS, SDS-PAGE, icIEF, IEF, western blot etc.)
• FTIR, CD, Intrinsic Fluorescence, DSC
• Other technologies/methodologies as required by management

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 adhocsample 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 Company’s culture, programs, and communication processes regarding quality, safety, and ethical practices
• All other duties as assigned

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