Senior Associate Scientist, Bioanalytical Lab

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 88,000 - 134,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Paid vacation

Paid sick leave

Paid holidays

Parental leave

Disability insurance

Life insurance

Employee assistance program

Fitness club membership

Pet insurance

Identity theft protection

Home and auto insurance discounts

Supplemental life insurance

Job summary

Meso Scale Diagnostics LLC in Gaithersburg, MD is seeking a Senior Associate Scientist for the Bioanalytical Laboratory to supervise daily operations and guide the team in transferring and qualifying new assays and platforms for regulated testing.

The role requires a Bachelor's in biology/chemistry with 6+ years in biological sample testing or assay development, strong knowledge of ligand-binding assays, GLP/GCLP training, and the ability to mentor staff in a fast-paced environment.

Qualifications

• Bachelor's degree in biology, chemistry, or related scientific discipline is required.
• Master's degree is preferred.
• Minimum of 6 years of hands-on work experience in biological sample testing or reagent/assay development in an industrial setting is preferred.
• Experience with running immunoassays/ligand-binding assays is highly preferred.
• 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 lab is required.

Responsibilities

• Supervise or independently execute studies in the Bioanalytical Laboratory per SOPs.
• Support lab team to procure reagents and materials for planned studies.
• Review documentation across projects including data capture, forms, logbooks, and batch records.
• Assist team with interpreting results and troubleshooting technical issues.
• Verify accuracy and validity of data; correct errors.
• Ensure out-of-spec results or deviations are properly documented.
• Present summaries to principal investigators.
• Supervise transfer and qualification/validation of assays/platforms for routine testing.
• Adhere to GLP/GCLP and safety policies; monitor lab safety practices.
• Mentor and evaluate performance; train lab staff.

Skills

Ligand-binding assays

Problem solving

Interpersonal skills

MS Office & SharePoint

Multi-tasking

Communication

Education

Bachelor's degree in biology/chemistry

Master's degree preferred

Tools

MS Office

SharePoint

Job description

POSITION SUMMARY

The Senior Associate Scientist, Bioanalytical Laboratory supervises daily laboratory operations and provides guidance and direction to laboratory team members to ensure on-time completion of customer projects. This includes the transfer and qualification/validation of newly developed assays, reagents and/or instruments intended for use in sample testing services that may be performed under regulatory compliance. This position may directly supervise the work of others and provide guidance to laboratory team.

DUTIES AND RESPONSIBILITIES

• Supervise or independently execute studies performed in the Bioanalytical Laboratory in accordance with applicable study plans and standard operating procedures (SOPs)
  • Support laboratory team as needed to procure reagents and materials required for planned studies
  • Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records
• Assist team members with interpreting results and troubleshooting technical issues
  • Verify the accuracy and validity of data; correct any errors
  • Ensure that out-of-specification results or deviations from protocol are properly documented
  • Present bioanalytical principal investigators (BPIs) with summaries of troubleshooting efforts and conclusions
• Supervise transfer and qualification/validation of newly developed or custom assays/platforms for routine testing in a regulated environment.
• Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of others within the laboratory and provide guidance on best practices for laboratory safety
• Adhere to principles of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) applicable to bioanalytical sample testing and analysis
• This role may supervise the work of others in all aforementioned areas of productivity and effectiveness
  • Responsible for supporting, mentoring and documenting performance evaluations for those they supervise
  • May be responsible for training and development of laboratory team members

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in biology, chemistry, or other related scientific discipline is required
  • Master's degree is preferred
• Minimum of 6 years of hands-on work experience in biological sample testing or reagent/assay development in an industrial setting is preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
  • Demonstrated proficiency in executing wide range of relevant assays can be substituted for up to 1 year of work experience
• Experience with running immunoassays/ligand-binding assays is highly preferred
• 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 lab is required

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 understanding and ability to execute and oversee assays run in a fast-paced environment with a focus on high-quality results.
• Ability to troubleshoot issues and provide solutions to technical challenges.
• Excellent interpersonal skills and ability to work well with all levels of employees as well as other parties/stakeholders involved with the company
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
  • Effectively communicate performance goals and expectations to direct reports
• Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum)
• Ability to multi-task and work productively in a demanding environment with changing priorities

PHYSICAL DEMANDS

• Up to 30% of the day may be spent at a lab bench, 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 30% 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

COMPENSATION SUMMARY

The annual base salary for this position ranges from $88,100 to $134,400. 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, paid parental leave, and 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.

• medical, dental, and vision coverage
• prescription benefits
• 401(k) plan with company matching
• flexible spending accounts
• company-paid short- and long-term disability insurance
• group life and accidental death and dismemberment insurance
• paid vacation
• paid sick leave
• paid holidays
• paid parental leave
• employee assistance program
• fitness club membership contribution
• pet insurance
• identity theft protection
• home and auto insurance discounts
• 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 click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

QUALIFICATIONS

Education

Bachelors of Biology (required)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This 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.