Senior Associate Scientist, Bioanalytical Lab

POSITION SUMMARY

The Senior Associate Scientist, Bioanalytical Laboratory supervises daily laboratory operations and provides guidance and direction to laboratory team members to ensure on-time completion of customer projects. This includes the transfer and qualification/validation of newly developed assays, reagents and/or instruments intended for use in sample testing services that may be performed under regulatory compliance. This position may directly supervise the work of others and provide guidance to laboratory team.

• Supervise or independently execute studies performed in the Bioanalytical Laboratory in accordance with applicable study plans and standard operating procedures (SOPs)
  • Support laboratory team as needed to procure reagents and materials required for planned studies
  • Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records
• Assist team members with interpreting results and troubleshooting technical issues
  • Verify the accuracy and validity of data; correct any errors
  • Ensure that out-of-specification results or deviations from protocol are properly documented
  • Present bioanalytical principal investigators (BPIs) with summaries of troubleshooting efforts and conclusions
• Supervise transfer and qualification/validation of newly developed or custom assays/platforms for routine testing in a regulated environment.
• Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of others within the laboratory and provide guidance on best practices for laboratory safety
• Adhere to principles of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) applicable to bioanalytical sample testing and analysis
• This role may supervise the work of others in all aforementioned areas of productivity and effectiveness
  • Responsible for supporting, mentoring and documenting performance evaluations for those they supervise
  • May be responsible for training and development of laboratory team members

• Bachelor's degree in biology, chemistry, or other related scientific discipline is required
  • Master's degree is preferred
• Minimum of 6 years of hands-on work experience in biological sample testing or reagent/assay development in an industrial setting is preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
  • Demonstrated proficiency in executing wide range of relevant assays 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 required
• Experience working in a high complexity/high throughput lab is required

• Strong 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
• Demonstrated understanding and ability to execute and oversee assays run in a fast-paced environment with a focus on high-quality results.
• Ability to troubleshoot issues and provide 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 30% 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

• This position is performed in a laboratory environment up to 30% of the time 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 materials and organisms

The annual…