Senior Research Associate

Position Summary:

The Senior Research Associate, Cellular Product Development position is a combination of laboratory and documentation support for the in vitro diagnostic (IVD) / companion diagnostic (CDx) product development programs. Performs routine immunological, molecular and cellular assay based assay services for government and commercial clients. Reliably performs services such as cell culture and bioassays such as luciferase-based neutralizing antibody assays involving virus transduction, serial dilution matrix for controls and serum samples and read out on a multi-mode spectrophotometer (BioTek or Molecular Devices) using Gen5 or Softmax software and analyzing data in Prism and Excel. Responsible for inventorying, processing and cryopreserving biological samples on assigned project(s). Duties may also include critical reagent production, coordinating feasibility, development, verification and validation experiments, contributing to design control documentation, recording and reporting results, preparation of samples and solutions, and maintenance of equipment.

 

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

• Independently plans and conducts bioassays of various scales and for different customers
• Performs QC analyses to ensure that results meet specifications. Monitors assays and troubleshoots, as required
• Performs research and development activities to support new product development.
• Assists Scientists to modify and re-optimize current assays or procedures to address changing technologies or the introduction of new assays
• Completes all paperwork completely and accurately for QA/QC and GLP/GCLP purposes using Good Documentation Practices (GDP) and updates computer tracking systems, as required
• Operates equipment such as plate reader and performs processes in accordance with SOPs
• Assists in the training of new and existing laboratory staff in accordance with SOPs.
• Provides technical input for feasibility, development, verification and validation protocols and reports, and other design control documentation
• Drafts and/or edits SOPs as needed, to include validation documents for new equipment, reagent/sample stability validation protocol and other quality documents
• Evaluates opportunities for revision of SOPs and makes necessary recommendations to improve efficiency and quality
• Organizes data prior to submission. Ensures lab maintenance activities and equipment calibration are performed according to schedule.
• Plans for raw material requirements, maintenance of appropriate inventory of reagents and submission of purchase orders
• Maintains a clean and safe lab environment
• Carry out other duties/projects as assigned

 

Qualifications:

 

Minimum Required:

• Bachelor’s Degree (Biology, Chemistry, Life Sciences or other related discipline)
• 4 years’ relevant laboratory experience or equivalent combination of education and experience

 

Other Required:

• Previous experience with cell-based assays such as neutralizing antibody measurement, ELISpot, or others
• Requires good attention to detail, excellent documentation skills and willingness to work well in a group environment
• Ability to interact and function in a highly productive work environment
• Ability to work independently
• Must be proficient using Microsoft office, specifically with Excel
• 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:

• Substantial cell culture experience
• Prior experience in a GLP or GMP environment
• Experience in regulated IVD product development under design control, including transfer, verification, and validation activities

 

 

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