Duties: 

. Responsible for qualification of product(s) in a lab setting following standard operating 

procedures. Will utilize basic laboratory techniques, calculations, materials measurement, 

operation of laboratory equipment and record keeping necessary to manufacture products.

. Will perform radioactive assays and analysis, TR-FRET assays, fluorescence based 

assays, and protein concentration assays.

. Responsible for Batch Data Records, notebooks, customer reports and work order 

documents.

. Utilize specialized technical knowledge and skills to make detailed observations and 

analyze data to ensure within operating parameters. 

. Advise manager of factors that may affect quality of product. Suggest options/ideas for 

corrective actions.

. Maintain equipment, product inventories and related records as assigned. 

. Note variances on manufacturing documents; audit and evaluate process documents and 

propose revisions. Complete, distribute and file records as required in accordance with 

Document Control Practices.

. Identify potential issues in the qualification process; report findings to team 

management and members for resolution or participate in troubleshooting.

. May lead process improvement projects

. Complete, distribute and file records; prepare ad hoc reports as requested.

. May perform other related duties as required and/or assigned.

. Advise the team lead/manager of factors that may affect quality of the product, initiate 

problem reports for deviations and non-conforming materials, and suggest options and ideas 

for corrective actions and preventive actions (CAPA).

Skills:

. Proficiency in the use of scientific laboratory techniques, equipment and materials:

. Radioactive Kinase Activity Assay

. TR-FRET Assay

. Fluorescence based assays

. Polyacrylamide and Agarose Gel Electrophoresis

. Western Blot

. Protein Concentration determination assay

. Buffer Preparation

. XL Fit Analysis

. Bench work both a lab environment and manufacturing facility with specialized 

equipment.

. Ability to carry out scientific procedures and make recommendations for improvement.

 chemicals and hazardous materials.

. The noise level in the work environment is usually moderate.

. May be required to stand for long periods of time while performing duties.

. May intermittently sit at desk/lab bench for a long period of time to perform 

experiments, write, and use a keyboard to communicate through written means.

Education:

. Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other 

related discipline and 4+ years of experience in a manufacturing or research laboratory.

. Master's degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other 

related discipline and 2+ years of experience.