Position Summary:

The Scientist (CDx) participates in IVD/CDx assay development, validation, and execution under design control process.  Performs clinical assays in CLIA/CAP/ISO accredited clinical immunology laboratory and supports development of new procedures and improvement of existing SOPs. Prepares critical reagents and reagent lot-to-lot evaluation and equipment comparability studies.

Essential functions of the job include but are not limited to:

Perform total antibody/neutralization antibody measurement and/or other immune monitoring assay Design and perform experiments, independently and accurately analyze and present data Assist in establishing and improving all laboratory procedures and required SOP documentation Responsible for assay trouble shooting and correcting routine scientific issues/problems Identify, update and suggest emerging laboratory techniques, and implement as directed by SME or senior leadership. Maintain and support safe lab practices and environment Work collaboratively with other technical teams in resource sharing and providing technical expertise Support new and ongoing equipment operational qualifications and instrument performance maintenance checks Ensures monthly reagent inventory counts are up to date Act as a scientific technology platform lead internally Write and prepare SOP, abstracts or draft scientific study report May present completed work to SME or senior leadership at appropriate scientific meetings and in publications Other duties as assigned

Qualifications:

Minimum Required:

Master’s Degree in life sciences or related field with 5 years of relevant laboratory experience, and/or Ph.D. degree in life sciences with 1 year of relevant laboratory experience

Other Required:

Expert level mammalian cell culture and plate-based cellular assay experience Excellent communication, interpersonal, and organizational skills required Must have the ability to organize and analyze data, as well as prepare data reports Must possess strong computational skills, preferably experienced with Word, Excel, Power Point, and GraphPad Prism Excellent use of judgment and discretion required Extended work hours may be occasionally necessary in order to meet business demands Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) Must be able to read, write, speak fluently and comprehend the English language

Preferred:

A solid understanding of current GXP or CAP/CLIA/ISO standards with industry working experience in cell/gene therapy field. Demonstrated skills with assays used for immune monitoring such as primary cell-based assays, total antibody measurement (ELISA and Mesoscale), and neutralizing antibody/transduction inhibition.