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 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
• Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records


• Provide technical guidance 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
• Review lot qualification data
• Monitor material inventory, project-specific materials in particular, to ensure no impediments in completing studies.
• Draft appropriate study plans, reports, and documents
• 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
• If applicable, establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
• May be 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 additional years of related experience
• Bachelor'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 required
• 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/fast-paced lab is required
• Supervisory/management experience desired

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 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 expectations


• Proficient 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 deliverables
• Basic 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 environment

COMPENSATION 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.