Lead Biologist - LIMS Implementation

Overview:

The Lead Biologist for the Laboratory Information Management System (LIMS) Implementation Team will serve as the technical expert for the laboratory staff. The Lead Biologists will participate in team meetings, assist with gathering user requirements, development, testing and implementing applications, training users as well as documenting the implementation process. 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 biomanufacturing environment with a strong working knowledge of laboratory and manufacturing processes. Candidate must have the ability to learn new technology platforms quickly and be able to train others on a consistent basis.

Responsibilities:

Adheres to appropriate quality guidelines.

Follows relevant SOPs and procedures with no supervision.

Receives and follows work orders, completing work as scheduled.

Communicates effectively with supervisor and others as appropriate on work status.

Performs viability and purity checks on biological materials.

Demonstrates competence in propagating and authenticating/characterizing a range of biological materials with no supervision.

Maintains knowledge of corporate and program policies and procedures.

Actively acquires new lab skills and specialized knowledge.

Reads and understands relevant scientific literature.

Compiles and documents data, as directed, for technical presentation.

Utilizes advance computer skills.

Offers suggestions for and contributes to optimization of processes.

Assumes a lead role in training others in laboratory and departmental procedures.

When appropriate, participates in scientific meetings, seminars, and workshops to stay abreast of technology advances.

Communicates effectively with members of all programs at ATCC as well as with outside collaborators.

Develops protocols to implement special tests relevant to program specialty.

Interacts with scientific community to answer inquiries and assist with technical problems, as needed.

Provides training for CSRs and TSRs, as requested.

Develops and evaluates new and/or existing assays for characterization/authentication of biological materials.

Troubleshoots out-of-specification results, analyzes data and oversees process changes.

Conducts research projects with minimal supervision from scientists, as directed.

Takes a leadership role in ensuring SOPs and departmental procedures are current and up-to-date.

Can represent ATCC as a sole participant in scientific meetings/trade shows.

May provide leadership in technology transfer to other ATCC programs.

Assists in formulating program goals.

Participates in managerial meetings, as needed.

Interacts closely with supervisor for management of program including assistance in development of area budget, as requested.

May oversee the work of others and maintain accountability for their work.

Writes and submits proposals for process development/optimization projects, carries out approved proposals under direction of supervisor, as appropriate.

Assumes a lead role in achieving program goals.

Can serve as coordinator and leader on a cross-functional project teams.

Qualifications:

Education and Experience:

Bachelor's degree in biology, chemistry or other related field and 7+ years of relevant experience OR

Master's degree in a science related field and 5+ years of relevant experience.

Experience within a cGMP environment is a plus.

Familiarity with biomanufacturing and QC processes.

Prior supervisory or lead role experience a plus.

Familiarity with LIMS platform(s) is desired.

Knowledge, Skills and Abilities:

Advance computer skills including expertise in the appropriate fields of ATCC's ERP system.

Strong written and oral communications skills with a desire to work closely with a wide range of disciplines and departments.

High level of motivation with the ability to work and think independently.

Proficient with Adobe, Microsoft Word, Outlook, Teams, and Excel.

Experience with workflow management systems.

Strong analytical, troubleshooting, and problem-solving abilities.

Proven track record leading cross functional projects.

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.

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.