Principal Scientist - Bioanalytical Sciences, Ligand Binding Assays

In this role, we will rely on you to:

• Function independently as a Principal Scientist and technical expert in the direction and execution of bioanalytical validations and biostudies as required.
• Provide oversight of the laboratory and mentor research staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation, as well as providing scientific expertise in study design, conduct, and interpretation.
• Independently review, interpret, analyze, evaluate, and discuss study results with research staff and Sponsors.
• Prepare high-quality final reports appropriate for the study, including integration of supporting subcontractor(s)’ reports into final reports as required.
• Supervise research and scientific staff within the function.
• Direct activities of assigned group(s), to ensure effective performance of function.
• Review protocols, reports, and scientific documents of direct reports as required.
• Provide scientific and technical leadership within the designated business unit to resolve analytical challenges in a timely fashion, and to evaluate new technologies for potential integration into the existing portfolio of services.
• Provide direct daily supervision and review the work of assigned departmental employees, to ensure scientific accuracy and adherence to departmental policies, practices, and procedures. Schedule and prioritize direct reports' workload.
• Ensure effective communication within departmental groups, to provide overlap of diverse expertise. Implement techniques to improve productivity, increase efficiencies, and maintain state-of-the-art practices.
• Monitor and increase the technical performance and expertise of departmental direct reports through coaching and mentoring. Prepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct reports.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
• Ensure that reports, raw data specimens, and supporting study documentation are transferred to the archives at the close of each study.
• Ensure effective communication within departmental groups to provide expertise in Sponsor calls, presentation materials, and pricing information.
• Perform other related duties as assigned.

To qualify specifically for this role, you will have:

• At least six years of relevant experience within contract research, academic or pharmaceutical industry, including expertise in the core competencies of validation and bioanalysis of study samples. Also requires a full understanding of GLPs, and departmental/company SOPs.
• Experience designing, planning, and executing bioanalytical assays (ADA, PK, Biomarker and Nab), method development and validation.
• Proficient in using common immunoassay platforms (ELISA, MSD, Luminex, etc.)
• Experience designing complex experiments & evaluating outcome vs. regulatory guidelines, white papers, and current industry practices.
• Experience troubleshooting problems and actively participating in the life cycle management of assays.
• Ability to manage multiple moderate to highly complex projects, prioritizes work, and meets deadlines.
• Capable of anticipating and recognizing potential problems within programs and effectively communicate alternatives to clients in a meaningful fashion.
• Must have proven record of delivering quality service to customers on time and on budget.
• Expert knowledge of applicable lab techniques.
• Familiarity with current industry trends and expectations.
• Demonstrated proficiency with validation, experimental design, troubleshooting, and method development as required by department.