Senior Research Associate Scientist

Job Description

Job Description

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Description :
Seeking a  Senior Associate Research Scientist I to provide analytical testing support for development and process characterization projects within the  Bioanalytics, Analytical Operations Laboratory in Research Triangle Park, NC.

• Perform analytical testing and analyses with minimal assistance using modern instrumental analytical techniques, including:
• • Karl Fischer moisture analysis
  • Coagulation assays
  • Enzymatic assays
  • Immunoassays
• Perform analytical testing in a  cGXP environment , including proper pipetting techniques such as volumetric, positive displacement, and reverse pipetting.
• Demonstrate a sound understanding of analytical test method principles.
• Apply applicable regulatory guidance related to cGXP testing, method validation, and CMC development.
• Operate and perform maintenance on modern analytical instruments, including:
• • Coulometric titrators
  • Coagulation analyzers
  • Immunonephelometers
  • Plate readers
• Accurately and contemporaneously document laboratory work in a research notebook or LIMS.
• Contribute to technical report writing as needed.
• Identify aberrant results, initiate investigations, and actively participate in problem-solving efforts.
• Demonstrate independent judgment and original thought when addressing laboratory issues.
• Maintain strong organization, attention to detail, and a proactive, results-oriented approach.
• Communicate effectively both verbally and in writing.
• Utilize Microsoft Office applications proficiently.

Required Qualifications

• Degree in a relevant field such as:
• • Biology
  • Biochemistry
  • Chemistry
  • Toxicology
• Master’s degree + 1 year of relevant experience , OR
• Bachelor’s degree + 3–4 years of relevant experience
• Relevant analytical testing experience in a  cGXP environment
• Experience with laboratory instrumentation and analytical testing techniques
• Strong documentation and organizational skills
• Strong verbal and written communication skills
• Ability to work independently and troubleshoot analytical issues

Preferred Experience

• Experience with cGXP testing, method validation, and CMC development
• Experience with Karl Fischer moisture analysis
• Experience with coagulation, enzymatic, and immunoassays
• Experience with LIMS and electronic laboratory documentation

Occupational Demands & Work Environment

• Work is performed in a  clinical and/or laboratory environment .
• Potential exposure to biological fluids and infectious organisms.
• Potential exposure to chemicals and electrical office equipment.
• Personal protective equipment is required, including protective eyewear, garments, and gloves.
• Frequently sits and bends neck for 4–6 hours per day.
• May stand and twist neck for 2–4 hours per day.
• Occasionally walks, bends, twists at the waist, and squats.
• Frequent hand movement with the ability to perform fast, simple movements of the fingers, hands, and wrists.
• Ability to perform precise, coordinated finger movements to grasp and manipulate objects.
• Moderate lifting of 15–30 lbs. , with a maximum lift of 35 lbs.
• May reach above and below shoulder height.
• Requires color perception/discrimination and near/far vision correctable to specified