Principal Scientist - BioPharma Sciences

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)’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 designated business unit to resolve analytical challenges promptly and evaluate new technologies for potential integration into 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 workload of direct reports 
• 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:

• Bachelors, Masters, or PhD in related field
• At least 10 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 complex projects, prioritizes work, and meets deadlines
• Capable of anticipating and recognizing potential problems within programs and effectively communicating alternatives to clients in a meaningful fashion  
• Must have a 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