Assistant Scientist

Description: Summarized Purpose:

Possesses an understanding of laboratory procedures and under general supervision can conduct complex analysis. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. The Associate Scientist will perform the following activities for the process development of large molecule drug substances. They will be responsible for implementing and optimizing experimental protocols, performing experiments and authoring scientific reports in the areas of purification, chemical modification, process development and scale-up of polysaccharides intermediates and drug substances. The Associate Scientist will be responsible for implementing and optimizing process and execution of downstream processes at different scales and in different research and development contexts.

Essential Functions

:Completion of process development experiments to support early development, optimization, scale-up and tech transfer for vaccine development program

s•Complete the design and execution of experiments to support process development of Client vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice

.•Focus on the development of new processes or improvement of existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts

.•Perform organic reactions and purify the intermediates or products independentl

y•Complete analysis and/or characterization of intermediates or drug substance

s•Complete data analysis from process development studie

s•Complete Tech transfer of developed processes to support GMP manufacturing

.•Complete archiving of raw and processed data as per Client polic

y•Operate and maintain designated lab equipment and train others as needed

.•Complete additional duties and responsibilities as required

.•Complete the documentation of experimental results as per GMP/GLP regulations

.•Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams at client and assist in submission to regulatory agencies such as FDA

.
Education and Experienc

e:• Bachelor's degree or equivalent and relevant formal academic / vocational qualificati

on• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years

).• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the rol

e.
Knowledge, Skills and Abiliti

es:•Industry experience with process development preferr

ed.•Knowledge in Carbohydrate Chemistry or Synthetic Organic Chemistry preferr

ed.•Experience in analytical chemistry and familiar with NMR, MS, HPLS, SEC/MALS prefer

red•Independent, detail-oriented, and organized with excellent oral and written communication skil

ls.•Demonstrated ability to work in a dynamic environment as a team player with a strong work eth

ic.•Ability to carry and move solvents, reagents, waste solvents or small equipment for up to 40 pounds in the l

ab.•Ability to maintain written records in the form of laboratory notebooks / electronic lab notebooks (ELN