We are seeking a highly motivated and detail oriented individual with strong We are seeking a highly motivated and detail oriented individual (e.g. Analyst) with strong expertise in life sciences and Laboratory Information Management Systems (LIMS) to support the modernization of our global Bioanalytical Sciences LIMS/ELN ecosystem.
This group performs assays for small molecule and peptide analysis using LC-MS/MS, ELISA assays using MSD and Spectrmax readers and Immunogenicity assays that are Anti-drug antibody and Neutralizing Antibody assays using MSD, Spectramax, Envision and Vicell type readers. This contract role offers the opportunity to contribute to a major digital transformation initiative within a world class scientific organization.
You will work closely with the global Pharmacokinetics and Drug Metabolism Bioanalytical Sciences (PKDM BA) team, collaborating with colleagues across sites in California and Germany, as well as with software vendors and internal subject matter experts. Your work will directly shape the implementation of our new LabVantage LIMS/ELN platform and help harmonize data and workflows across our global bioanalytical community.
Key Responsibilities:- Partner with PKDM-BA and Research Informatics SMEs to understand workflows, map business processes, and define system requirements for experimental data and metadata management.
Master Data Integration- Lead the integration of assay and study metadata, reagent and equipment information, and experimental raw data/results from multiple legacy systems into a unified global LIMS environment.
- 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 company 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:- 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