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
Bachelor’s Degree (Biology, Chemistry, Life Sciences or other related discipline)
4 years’ relevant laboratory experience or equivalent combination of education and experience
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
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
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.