Builds inventory from each type of controlled chamber (e.g., refrigerator, freezer, LN2, Ambient, etc.) into an inventory management system.
Testing & Compliance
Contribute to test planning and execution to ensure the LIMS/ELN solution meets specifications, supports bioanalytical workflows, and complies with standards and regulatory requirements (including GxP and FDA 21 CFR Part 11).
Documentation
Create and maintain clear, comprehensive documentation covering requirements, processes, data flows, configurations, and user guides.
Training & User Support
Assist in developing and delivering training to end users adopting the new LIMS/ELN system.
Collaboration & Communication
Serve as a liaison between PKDM-BA labs (ATO and ASF), research teams, technology teams, and software vendors.
Foster strong collaboration across diverse groups including bench scientists, data scientists, software engineers, and data engineers.
Qualifications & Skills
Education & Experience
Bachelors in life sciences, computer sciences, or a related field
Minimum 2 years of direct experience working with laboratory software and electronic data processes in the pharma/biotech industry.
Regulatory & Quality Knowledge
Experience with Laboratory Information Management Systems and Electronica Laboratory Notebooks (e.g., Watson LIMS, StarLIMS, IDBS ELN, Others) would be helpful.
Experience in GxP environments and understanding of computerized system validation and regulatory frameworks (e.g., FDA 21 CFR Part 58 and 11) is desired.
Soft Skills & Ways of Working
Self-driven and consistent demonstration of initiative
Ability to multi-task activities while maintaining attention to details
Excellent communication skills
Strong analytical, organizational, and problem solving abilities.
Demonstrated success collaborating with cross functional scientific and technical teams.
Adaptability, energy, and willingness to work across time zones.
Innovative mindset with a track record of driving ideas to implementation.
Ability to work effectively in a cross-functional, team matrix environment
Comfortable interacting with a diverse team with wide-ranging skillsets.
Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio and Outlook
Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommended
If youre passionate about enabling cutting edge science through modern informatics solutions and thrive in a collaborative, fast paced environment, wed love to hear from you.
