Associate Scientist II – BioChemical Analysis
Job Description
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.
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
▪ 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
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 Company’s culture, programs, and communication processes regarding quality, safety, and ethical practices
▪ All other duties as assigned
▪ 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 Company’s 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
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
