ATCC is seeking a full time direct hire Lead Biologist to work in Manassas VA. The Lead Biologist for the Laboratory Information Management System (LIMS) Implementation Team will serve as the technical expert for the laboratory staff. The Lead Biologist will Participate in teams meetings,assist with gathering user requirements, development, testing and implementing applications. The Lead biologist will work closely with other functional departments and users to generate user requirements and understand system functionality and use, as well as assist with administrative functions involving template configuration and implementation. The Lead Biologist should have a strong background in a bio- manufacturing environment with a strong working knowledge of laboratory and manufacturing processes.

The Lead Biologist is responsible for conducting complex experiments in the studying of biological materials and processes. Taking a lead role, they participate and coordinate the work of others that conduct testing and studies to advance product development and research. They collect and report on data and findings.

The Lead Biologist determines methods for monitoring laboratory supplies, equipment, and cleanliness. They handle complex issues where analysis of data requires evaluation of variable factors. The Lead Biologist resolves a wide range of issues in creative and effective ways. They exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining solutions.

1. Determine the methods and procedures for conducting diverse experiments to study the effects of varying materials, chemicals, environments, and physical conditions on biological materials and processes using standard scientific techniques and methods. Perform viability and purity checks on biological materials.
2. Decide which biological techniques are utilized to contribute to tests and studies that advance product research and development objectives.
3. Collect and analyze complex data, make detailed observations, and interpret results. Test, validate, and document results neatly and accurately in notebooks, batch records and databases.
4. Perform research and/or development in collaboration with others for projects.
5. Document, present, and draw meaningful conclusions of research findings to help inform and support difficult decisions. Fill in for supervisor in attending meetings, as needed.
6. Investigate, create, and develop new methods and technologies for project advancement.
7. Finalize research documentation, such as reports, summaries, publications, and presentations. Prepare scientific documentation such as grants, and regulatory submissions manuscripts.
8. Lead laboratory operations by determining methods for ordering, monitoring, and reporting on department supply levels, monitoring equipment functionality and cleaning laboratory equipment.
9. Remain current and in advance of biology research methods, techniques, and developments.
10. Lead, guide, and coordinate the work of laboratory staff within assigned projects. Prepare for internal and external audits.

Education and Experience:

• Bachelor's degree and 8 or more years' experience, including 0-2 years' supervisory experience or equivalent experience.
• Familiarity with bio-manufacturing and QC processes.
• Lead role experience a plus.
• Familiarity with LIMS platform(s) is required.

 Knowledge, Skills and Abilities:

• Advanced computer skills including ERP expertise and LIMS Platform(s) knowledge.
• Proficient with Adobe, Microsoft Word, Outlook, Teams, and Excel.
• High level of motivation with the ability to work and think independently.
• Experience with workflow management systems.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Proven track record leading cross functional projects.
• Ability to lead others in the attainment of program goals and objectives.
• Maintains accurate records.
• Attention to detail.
• Experience in complex lab skills and safety procedures including proper handling of chemicals and/or biologicals.
• Demonstrates leadership qualities and ability to function in a team environment.
• Demonstrates aseptic techniques appropriate to assigned discipline.
• Ability to analyze and interpret complex data.
• Ability to exercise judgment and make good decisions.
• Understands new and/or existing assays for characterization/authentication of biological materials.
• Assumes a Lead role in training others in LIMS procedures.
• Ability to handle multiple tasks and responsibilities of a complex nature, simultaneously.
• Has an understanding of out-of-specification results, data analysis and process changes.

Other Duties:

• Perform other duties as assigned.

Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge. 

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.