Job Description
Job Title: Research Associate/Sr. Research Associate
Department: Research and Development
Reports to: Director or Scientist Level
Position Overview
Pierian Bioscience is a personalized medicine company that is developing innovative treatment directing diagnostic assays to guide physicians in improving treatment outcomes for cancer patients. We are currently focused on the ChemoINTEL and ImmunoINTEL technology platforms in support of our In Vitro Diagnostic (IVD) product development, clinical validation studies and biopharma collaborative projects.
The Research Associate will report to an assigned Director or Scientist and will perform all required assay development experiments and process improvement activities in accordance with established procedures to meet all Good Laboratory Practices (GLP) regulatory requirements set forth in the FDA guidelines. She/he will work closely with development, manufacturing, clinical and quality staff to foster a team atmosphere striving for continued technical innovations, process improvement and centres of excellence.
Essential Job Functions
- Actively participate as part of the assay development, laboratory operations and manufacturing teams, following Good Laboratory Practices as defined in approved SOPs
- Perform assay development tasks independently
- Perform all aspects of assigned technical processes
- Perform instrument QC and preventative maintenance
- Assist with assay development process improvements coordinated with heads of Development, Manufacturing, and Quality Assurance
- Participate in drafting and execution of study plans to optimize assay/reagent parameters and product configuration
- Participate in experimental data analysis, interpretation, and study report writing
- Present data for review and discussion at individual and group laboratory meetings
- Follow laboratory protocols rigorously to execute experiments, thoroughly document all activities and maintain formal notebook. Understand the experimental goals and results and provide feedback and basic troubleshooting as necessary
- Demonstrate training and proficiency in clinical sample processing for all assay development and FDA clinical trial validation studies
- As part of ongoing technical growth, gain further understanding of experimental principles by reading appropriate literature
- Demonstrate good laboratory practices in the handling of clinical specimens, cell culture, and other reagents, including antibodies, modulators, drugs and small molecule inhibitors
- Work cooperatively in a team environment; supporting senior scientific staff and co-workers
- Provide training to laboratory and manufacturing lab staff on technical tasks and compliance-related activities
- Prepares and qualifies research buffers and other reagents
Non-Essential Job Functions:
- May be required to review and update SOPs, tracking logs, and material/reagent specifications under design control processes
- Material ordering, receiving and inventory control processes
Technical Experience/Requirements:
- Research Associate: B.S. with minimum of two (2) years relevant laboratory experience
- Senior Research Associate: B.S. with minimum of eight (8) years relevant laboratory experience or M.S. with minimum of two (2) years relevant laboratory experience
- Prior experience with molecular based clinical assays with an emphasis on fluorescent image based platforms (image analysis, flow cytometry, IHC, ELISA and Luminex experience a definite plus)
- Prior experience operating under GMP, GLP, and GCP regulated environment desired
- Prior experience conducting clinical validation studies, clinical trials, and/or submissions for FDA 510k and PMA clearance is desirable
Education/Experience Requirements
- Bachelors or Masters in one of the Life Sciences; immunology, cell biology, genetics, molecular biology, biomedical engineering, biomedical technologies or biochemistry preferred
Knowledge, Skills, and Abilities (KSAs)
- Leadership, integrity and initiative abilities
- Excellent written and oral communication skills
- Essential reading, research and writing skills
- Critical thinking, judgment and decision making skills
- Competency in MS Office products and ability to quickly learn other software applications
NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as requested to meet the ongoing needs of the organization. Pierian Biosciences is an Equal Opportunity Employer with a strong commitment to the achievement of excellence and diversity.
To apply please forward your CV and Cover Letter to GeneralAttendant@pierianbio.com, your subject line should read ‘Research Associate Application – (Your Full Name)’
