Senior Research Associate (Bioanalytical)

Precision for Medicine•Frederick, MD

12d•Onsite

About The Position

Reliably performs and provides bioanalysis services for commercial clients using Softmax or MSD benchwork software and analyzing data in Prism and Excel. May also perform critical reagent production, plate based assays and DNA/RNA extraction. Duties also include recording and reporting results, preparation of samples and reagent solutions, and maintenance of equipment. Essential functions of the job include but are not limited to: Maintains instrument and reagent inventory per SOPs Conducts immunological assays including ADA, PK or Potency assay, as well as cytokine measurement etc Independently plans and conducts bioassays various scales and for different customers Performs QC analyses to ensure that results meet specifications. Monitors assays and trouble shoots, as appropriate Performs research and development activities to support new product development. Performs new assay development as needed 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 purposes using Good Documentation Practices (GDP) and updates computer tracking systems, as required Operates equipment such as spectrophotometer, MSD plate reader, Quanterix, or Nanostring and performs processes in accordance with SOPs Assists in the training of new and existing laboratory staff in accordance with SOPs Drafts and/or edits SOPs as needed, to include validation documents for new equipment, new documents 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 is 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

Requirements

Bachelor’s Degree (Biology, Chemistry or Life Sciences) or equivalent combination of education and experience
4 years’ relevant laboratory experience or equivalent combination of education and experience
Previous experience with ELISA, MSD or Quanterix based platform or Nanostring.
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

Nice To Haves

Substantial ligand binding assay experience
Prior experience in a GLP or GMP or GCLP environment

Responsibilities

Maintains instrument and reagent inventory per SOPs
Conducts immunological assays including ADA, PK or Potency assay, as well as cytokine measurement etc
Independently plans and conducts bioassays various scales and for different customers
Performs QC analyses to ensure that results meet specifications.
Monitors assays and trouble shoots, as appropriate
Performs research and development activities to support new product development.
Performs new assay development as needed
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 purposes using Good Documentation Practices (GDP) and updates computer tracking systems, as required
Operates equipment such as spectrophotometer, MSD plate reader, Quanterix, or Nanostring and performs processes in accordance with SOPs
Assists in the training of new and existing laboratory staff in accordance with SOPs
Drafts and/or edits SOPs as needed, to include validation documents for new equipment, new documents 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 is 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