This Lead Biologist position requires experience with virology, molecular and cellular biology techniques, such as aseptic technique, general cell culture, harvest, and purification methods. This position requires experience with process scale up and tech transfer, as well as previous experience working in a controlled regulated environment.
The Lead Biologist is responsible for conducting complex experiments in the studying of biological materials and processes and for excecution production orders for Manufacturing. Taking a lead role, they participate and coordinate the lab work with Biologists and other support groups. They follow Good Documentation Practices and comply with ISO standards and facilitate a culture of compliance and safety within the lab.
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. Responsibilities 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.Decide which biological techniques are utilized to contribute to tests and studies that advance product research and development objectives.Utilize a variety of virology, molecular and cellular biology techniques to contribute to product development and manufacturing. Design and conduct experiments to support process scale-up and tech transfer initiatives.Collaborate with Research & Development colleagues on new product tech transfers and serve as a Subject Matter Expert for BioProduction on tech transfer project teams.Prepare, review, and approve documentation to support tech transfer of new products and processes into Manufacturing including batch records, SOPs, material specifications, and change controls.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.Perform research and/or development in collaboration with others for projects.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.Investigate, create, and develop new methods and technologies for project advancement.Finalize research documentation, such as reports, summaries, publications, and presentations. Prepare scientific documentation such as grants, and regulatory submissions manuscripts.Lead laboratory operations by determining methods for ordering, monitoring, and reporting on department supply levels, monitoring equipment functionality and cleaning laboratory equipment.Remain current and in advance of biology research methods, techniques, and developments.Lead, guide, and coordinate the work of laboratory staff within assigned projects. Prepare for internal and external audits. Qualifications Education and Experience:
Knowledge, Skills and Abilities:
- Bachelor's degree and 8 or more years' experience, including 0-2 years' supervisory experience or equivalent experience.
- Experience with virology, molecular and cellular biology techniques, such as aseptic technique, general cell culture, harvest, and purification methods.
- Experience with process scale up and tech transfer is required.
- Advance computer skills including expertise in the appropriate fields of ATCC's ERP system.
- Serves as a technical expert within relevant scientific discipline.
- Ability to work independently.
- 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.
- Ability to handle multiple tasks and responsibilities of a complex nature, simultaneously.
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.
- Perform other duties as assigned.