Bioanalytical Scientist

POSITION SUMMARY:The 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 sample analysis and validation 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 may directly supervise the work of others. DUTIES AND RESPONSIBILITIES: Manage sample analysis and method validation projects performed in the Bioanalytical Laboratory utilizing appropriate protocols and in compliance with Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) as requiredPlan and oversee individual experiments as required for each projectEnsure resources (reagents, materials, equipment) are available and appropriate for intended use by laboratory staff Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch recordsProvide technical guidance to bioanalytical testing staff and other team members as needed in the execution of bioanalytical projectsInterpret, organize, and present study results as required for each projectReview lot qualification dataMonitor material inventory, project-specific materials in particular, to ensure no impediments in completing studies.Draft appropriate study plans, reports, and documentsReview analytical reports for completeness and compliance with study requirementsAdhere to principles of GLP/GCLP applicable to bioanalytical sample testing, data analysis and reportingAdhere 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 safetyIf applicable, establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performanceMay be responsible for training and development of laboratory team EXPERIENCE AND QUALIFICATIONS: Ph.D. in Biology, Chemistry, or related scientific discipline preferredAdditional postdoctoral or industrial experience preferredMaster's degree may be considered with additional years of related experienceBachelor's degree may be considered with additional years of experience including a minimum of 4 years of hands-on experience with the MSD platform Minimum of 4 years of hands-on laboratory work experience is required; experience in biological sample testing is 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 requiredExperience with running assays on the MSD platform is highly preferredTraining in and experience with Biosafety Level 2 (BSL-2) techniques is requiredTraining in and experience with GLP and/or GCLP is requiredExperience working in a high complexity/high throughput/fast-paced lab is requiredSupervisory/management experience desired KNOWLEDGE, SKILLS AND ABILITIES: Strong understanding of ligand-binding assaysStrong scientific fundamentals and analytical backgroundLogical problem solving and demonstrated ability to initiate, organize and implement process improvement activities Demonstrated ability to execute and oversee assays run in a fast-paced environment with a focus on high-quality results. Demonstrated ability to troubleshoot complex issues and provide solutions to technical challenges. Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.Excellent interpersonal skills and ability to work well with employees at all levels Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data Effectively communicate performance goals and expectationsProficient in MS Office suite; familiar with electronic file management using SharePoint (end user minimum) Strong organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverablesBasic statistical knowledge PHYSICAL DEMANDS: Up to 20% of the day may be spent in the laboratory, and may involve repetitive tasks (e.g., pipetting)Ability to lift/move up to 25 pounds WORK ENVIRONMENT: This position is performed in a laboratory environment up to 20% 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 Other assigned responsibilities will be performed in a traditional office environmentCOMPENSATION SUMMARY The annual base salary for this position ranges from $101,400. to $154,700. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success. BENEFITS SUMMARY At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance. EEO/AA STATEMENT MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.