Scientist – CDx

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.