- - ELN
- Indianapolis, IN, USA
- Full Time
AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support for development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.
AITB is the first and only CRO in the world to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system (ELN). With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.
To support our continued growth, AITB is seeking an Application Administrator to work in our Indianapolis facility. The Application Administrator is a technology-oriented professional, trained as a scientist, who is responsible for the administrative activities of IDBS E-Workbook Suite, Watson LIMS, BioDocs - electronic document management system (e-DMS), and the electronic training management system (e-TMS). Prior analytical laboratory experience is preferred.
Summary of Job Responsibilities
• Designs and builds ELN templates that are used to capture required documentation for workflows and processes in the laboratory and business office.
• Writes/executes test scripts for the validation of ELN templates assuring that the information provided is accurate and in alignment with regulatory guidelines, as needed.
• Works with management and staff to improve ELN templates and procedures to increase efficiency, productivity, and quality.
• Troubleshoots ELN template and experiment issues daily.
• Maintains the ELN catalog dictionaries, security, hierarchy, and configuration.
• Serves as subject matter expert on the applications.
• Provides user training for each application.
• Maintains application user accounts where applicable.
• Active participant in formal software validation for applications.
• Provides technical information and resolve problems.
• Develops and maintains good working relationships with internal and external customers.
• Authors papers and/or presentations and represents AIT Bioscience at meetings and trade shows as assigned.
• Travel as needed and attend meetings and workshops.
• Bachelor's degree in a physical/life sciences field
• 3-5 years of experience working in a science focused position, preferably including in a regulatory-compliant (GxP) environment
• Previous software administration experience is preferred
• Knowledge of preclinical and clinical drug development, clinical study designs and procedures
• Knowledge and hands-on experience with laboratory processes and procedures, preferably in a regulatory-compliant (GxP) laboratory.
• Knowledge of current United States FDA, and EMA requirements and guidance on bioanalytical method development and sample analysis for large and small molecules, familiarity with OEDC and ICH requirements, and current best practices in bioanalysis.
• Planning/Organization - Ability to manage multiple projects and tight deadlines, with a potentially heavy workload; willing to seek additional resources if needed to meet deadlines.
• Problem Solving – Skilled in diagnosing and evaluating problems, thinking "outside the box", interfacing with internal staff, Sponsors and Vendors and working jointly to achieve a solution.
• Written Communication – Excellent writing ability for preparation of study reports, papers, SOPs and communications with Sponsors.
• Oral Communication – Presents concepts logically and in an organized fashion; listens and responds well to questions; demonstrates presentation skills; participates in meetings
• Professionalism – Reacts well under pressure; treats Sponsors and co-workers with respect, regardless of their status or position; communicates with tact; follows through on commitments; accepts responsibility for own actions.
• Adaptability – Manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events
• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives
• Ethics – Treats people with respect; keeps commitments; inspires the trust of others; works with integrity and ethically; upholds organizational values
• Judgment – Displays ability to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; includes appropriate people in decision-making process; makes timely decisions
• Computer Skills – Strong working knowledge of Microsoft Office applications, particularly Word, Excel, Outlook, and PowerPoint; Watson LIMS; required use of IDBS Electronic Laboratory Notebook as core laboratory tool (after training) for all lab activities.