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
- Strong scientific fundamentals and analytical background
- Demonstrated ability for logical problem solving and initiation, organization and implementation of process improvement activities
- Demonstrated ability to oversee analytical testing with a focus on high-quality results.
- Demonstrated ability to troubleshoot technical issues and provide solutions to complex problems.
- Effective leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the 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
- Proficiency in MS Office suite; familiar with electronic file management using SharePoint (end user minimum)
- Excellent 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
- Intermediate level statistical knowledge
PHYSICAL DEMANDS:
- This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and laboratory.
WORK ENVIRONMENT:
- This position is primarily performed in a traditional office environment
- Other assigned responsibilities will be performed in a laboratory environment up to 20% of the time, working with staff who are handling chemical reagents and performing some Biosafety Level 2 work
- May involve handling of BSL-2 materials and organisms including human blood and/or blood products
COMPENSATION SUMMARY:
The annual base salary for this position ranges from $116,600 to $177,800. 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.
