Position Summary:
The Research Associate of Bioanalytical Assays will perform biomarker MSD, ELISA, enzyme kinetic and Quanterix SIMOA immunology, neurology and oncology assay services for commercial clients. This role will analyze all data produced independently in Workbench or Softmax and Excel prior to peer review to conduct weekly daily biomarker assays. The work requires full competency assessment in serial dilution of matrix for controls and serum sample preparation, accurate pipetting skills, good math skills and ability to analyze data in Workbench, Softmax and Excel on a daily basis. This role will also perform biomaterial (serum, plasma, CSF, urine) reagent aliquotting, instrument calibration tests, produce data summaries and has the potential to take part in other related cell-based gene therapy assays. Duties also include participating with Scientists in assay development, verification and validation, recording and reporting results, preparation of samples and solutions, and maintenance of equipment.
Essential functions of the job include but are not limited to:
- Perform ELISA (commercial kits and custom assays), MSD (V-plex, R-plex, U-plex), enzyme kinetic and Quanterix SIMOA bead-based assays to measure cytokines, proteins and/or other biomarkers
- Perform experiments independently and accurately analyze and present data
- Independently plans and conducts plate-based assays at various scales and for different customers
- Perform experiments requiring dilutions, pipetting, calculations, spike/recovery assessments using Excel and graphing in Prism; produces Powerpoint slides for meetings to summarize results per the timeline
- Perform QC analyses (using Softmax, Workbench, etc) to ensure that results meet specifications
- Monitor assays and trouble shoots, as appropriate; ensures quality in the performance of each assay
- Perform research and development activities to support new product development
- Assist Scientists to modify and re-optimize current assays or procedures to address changing technologies or the introduction of new assays
- May conduct other immunological assays including total antibody and NAb assay, etc. per SOPs
- Complete all paperwork completely and accurately for QA/QC and GLP purposes using Good Documentation Practices (GDP) and updates computer tracking systems, as required
- Operate equipment such as Molecular Devices spectrophotometer, MSD plate reader and Quanterix SR-X and performs processes in accordance with SOPs
- Assist in the training of new and existing laboratory staff in accordance with SOPs.
- Draft and/or edit SOPs as needed, to include validation documents for new equipment, new documents and other quality documents
- Evaluate opportunities for revision of SOPs and makes necessary recommendations to improve efficiency and quality
- Organize data prior to submission. Ensures lab maintenance activities and equipment calibration is performed according to schedule.
- Plan for raw material requirements, maintenance of appropriate inventory of reagents and submission of purchase orders
- Maintain a clean and safe lab environment
- Carry out other duties/projects as assigned
Qualifications:
Minimum Required:
- Bachelor’s Degree (Biology, Chemistry or Life Sciences) or equivalent combination of education and experience
- 2 years of relevant laboratory experience
Other Required:
- Requires good attention to detail, excellent documentation skills and willingness to work well in a group environment
- Excellent pipetting skills, including use of multi-channel pipettes
- Ability to interact and function in a highly productive work environment
- Ability to work independently
- Requires accurate data analysis experience (Workbench)
- Must be proficient using Microsoft office, specifically with Excel and have experience with plate readers
- Must be able to present data using Excel and PowerPoint
- 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:
- Experience with one or more of the following platforms: MSD, Quanterix, Luminex, Gyros, ELLA, or AlphaLisa
- GxP laboratory environment experience
- Prior experience in a GLP/GCLP or GMP environment
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
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