ELN Administrator

About the role

Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides as an Electronic Laboratory Notebook (ELN) Administrator.

Responsibilities

• Provide technical and end user support to ensure efficient and trouble-free operation of the ELN system.
• Configure, deploy, and manage IDBS ELN templates and other user-managed information for efficient data recording and retrieval.
• Maintain a strong working relationship with internal AFS customers, other KBI site AFS departments, the ELN Product Owner, and IT to facilitate the implementation of new releases, configuration updates, or addition of new features, ensuring enhanced functionality and user experience based on business needs.
• Serve as the voice of customer for AFS ELN users, receiving and disseminating end-user feedback regarding the system to AFS management, the Product Owner and IT.
• Lead and/or participate in system improvement initiatives.
• Train team members on ELN usage and best practices.
• Support client/regulatory audits as necessary.
• Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and compliance.
• Able to react to change productively and handle other essential tasks as assigned.

Requirements

• Bachelor’s degree in computer science, pharmaceutical science, biology, chemistry, or other related science/IT.
• Minimum of seven years of experience working in the pharmaceutical industry.
• Must have experience working within an electronic laboratory notebook system in the pharmaceutical industry, preferably IDBS.
• Knowledge and understanding of common analytical laboratory processes and assays (e.g., chromatography, rDNA, etc.), as well as quality control measures in the laboratory.
• Experience in distilling complex procedures/assays into a standardized template.
• Capable of identifying key steps, variables, and parameters within experiments and translating this knowledge into clear, structured formats.
• Previous work in a regulated environment (FDA, EPA, etc.) is required.
• Advanced proficiency in electronic laboratory notebook systems, IDBS preferred.

Skills

Proven ability to work independently and as a part of the team to resolve issues
Strong decision making and problem-solving skills
Demonstrated level of respect for individuals
High level of integrity and personal responsibility
Strong collaboration and team building skills; strong communication and interpersonal skills
Strong orientation for quality and customer service

Benefits

KBI offers a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

Pay

$84,000 - $115,500

Schedule

N/A