Associate Scientist, Bioanalytical Lab

Job Category
:
Quality - Control/Assur/Regul

Requisition Number
: ASSOC
003805

Gaithersburg, Maryland, Gaithersburg, MD 20877, USA

POSITION SUMMARY:

The Bioanalytical Associate Scientist is responsible for independently executing experiments in support of sample testing and method validation projects. This is a laboratory-based position whose primary function is independently executing various types of assays with relatively high throughput in support of bioanalytical projects. This position manages multiple projects with high quality results and provides guidance to other team members regarding assay execution as needed.

• Independently execute sample analysis in consultation with the Bioanalytical Principal Investigator (BPI)
• Independently execute method validation assays in consultation with the BPI
• Function as lead analyst in multi-panel testing, overseeing individual runs by more junior analysts
• Independently perform lot qualification of assay reagents
• Independently review analytical data and perform data analysis
• Provide training and mentoring to other laboratory employees on assay execution and laboratory best practices
• Complete test records in compliance with MSD’s Good Documentation Practicies (GDP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) requirements, applicable Standard Operating Procedures (SOPs) and study plans
• Perform peer review of test records generated by other testing staff for GDP compliance
• Lead and participate in general lab maintenance initiatives
• Lead and participate in materials/reagent inventory
• Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE)
• Adhere to applicable principles of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP)

• Bachelor’s degree in biology, chemistry, or other related scientific discipline, or equivalent work experience is required
• Master’s degree is preferred
• Minimum 4 years of hands‑on work experience in biological sample testing or reagent/assay development in an industrial setting is preferred; academic setting considered
• Demonstrated proficiency in executing wide range of relevant assays utilized can be substituted for up to 1 year of work experience
• Experience with running immunoassays/ligand‑binding assays is highly preferred
• Experience with running assays on the MSD platform is highly preferred
• Training in and experience with Biosafety Level 2 (BSL‑2) techniques is required
• Training in and experience with GLP and/or GCLP is highly preferred
• Experience working in a high complexity/high throughput lab is highly preferred

• Understanding of ligand‑binding assays
• Strong scientific fundamentals and analytical background
• Logical problem solving and demonstrated ability to initiate, organize and implement process improvement activities
• Ability to execute and oversee complex assays run in a relatively high throughput environment with a focus on high quality results
• Ability to lead, train and guide others to understand and accomplish tasks/duties/responsibilities
• Ability to troubleshoot issues and recommend solutions to technical challenges
• Excellent interpersonal skills and ability to work well with all levels of employees as well as other parties/stakeholders involved with the company
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
• Effectively communicate performance goals and expectations to direct reports
• Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum)
• Ability to multi‑task and work productively in a demanding environment with changing priorities

• Up to 60 % of the day may be spent at a lab bench, and may involve repetitive tasks (e.g., pipetting)
• Ability to lift/move up to 25 pounds

• Laboratory environment working with chemical reagents and Biosafety Level 2 materials including human blood/blood products and other potentially infectious human samples
• May involve handling of pathogenic…