Senior Bioanalytical Scientist

POSITION SUMMARY:

The Senior Bioanalytical Scientist functions as a Bioanalytical Principal Investigator (BPI), providing technical guidance and expertise in executing sample analysis studies and analytical method validations. This includes managing multiple projects, overseeing the analytical schedule in coordination with laboratory management, and providing guidance to bioanalytical testing staff and other team members as needed. This role will interact with customers to ensure the studies are managed under the appropriate regulatory scope, review study data, and conduct applicable data analysis as required by each project. This position will directly supervise the work of others.

DUTIES AND RESPONSIBILITIES:

• Manage multiple sample analysis and method validation projects concurrently in the Bioanalytical Laboratory utilizing appropriate protocols and in compliance with Good Laboratory Practice (GLP)  and/or Good Clinical Laboratory Practice (GCLP) as required
• Plan and oversee individual experiments as required for each project
• Ensure resources (reagents, materials, equipment) are available and appropriate for intended use by laboratory staff
• Approve documentation associated with executed projects including data analysis and reporting
• Provide technical guidance and mentoring to bioanalytical testing staff and other team members as needed in the execution of bioanalytical projects
• Interpret, organize and present study results as required for each project
• This role may also oversee/mentor more junior team members in the interpretation, organization, and presentation of study results
• Verify the accuracy and validity of data
• Ensure that out-of-specification results or deviations from protocol are properly documented
• Present summaries of troubleshooting efforts and proposed solutions/conclusions to laboratory management and other BAL scientific staff
• Review lot qualification data
• Monitor material inventory, project-specific materials in particular, to ensure no impediments to completing studies.
• Draft appropriate study plans, reports, and documents and review project-related documentation generated by others
• Review analytical reports for completeness and compliance with study requirements
• Adhere to principles of GLP/GCLP applicable to bioanalytical sample testing, data analysis and reporting
• Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of laboratory staff and proactively address departures from best practices for laboratory safety
• Establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
• Responsible for training and development of laboratory team

EXPERIENCE AND QUALIFICATIONS:

• Ph.D. in Biology, Chemistry, or related scientific discipline preferred
• Additional postdoctoral or industrial experience preferred
• Master’s degree may be considered with a minimum of 3 additional years of related experience
• Bachelor’s degree may be considered with additional years of experience including a minimum of 6 years of hands-on experience with the MSD platform
• Minimum of 6 years of hands-on laboratory work experience is required
• Minimum of 8 years of overall experience in positions of increasing responsibility is required; experience in biological sample testing is highly preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
• Experience with running immunoassays/ligand-binding assays is required
• Experience with running assays on the MSD platform is required
• 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
• Minimum of two years of supervisory/mentoring/management experience is required

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong understanding of ligand-binding assays