DET-ET-LIMS-Manager-GDSN02
Job description
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.
Manager – LIMS Implementation and Strategy Life Sciences Sector
Experience: 7–10 years
Education: M.Tech / M.Sc / Ph.D. in Life Sciences, Biotechnology, Bioinformatics, Chemistry, or related fields
Preferred Background: Life Sciences Consulting | Laboratory Informatics | LIMS Transformation
Role Summary:
We are seeking an experienced Manager – Laboratory Information Management Systems (LIMS) to join our growing Life Sciences Consulting practice. This role focuses on advising pharmaceutical and biotech clients on the transformation and optimization of laboratory informatics systems, particularly LIMS, across R&D, QA/QC, manufacturing, and regulatory environments.
Key Responsibilities:
- Lead and manage end-to-end consulting engagements involving LIMS system strategy, selection, implementation, and optimization.
- Work closely with client stakeholders (QA, QC, R&D, IT, Compliance) to assess current-state processes and define future-state digital lab strategies.
- Design workflows for lab digitization, integration of instruments, and data capture solutions aligned with business and regulatory needs.
- Collaborate with vendor teams on LIMS configuration, validation, and rollout plans.
- Provide thought leadership on emerging lab digitalization trends, such as integration with ELN, LES, CDS, and IoT for Smart Labs.
Must-Have Skills:
- Proven expertise in one or more LIMS platforms (e.g., LabWare, STARLIMS, Thermo Fisher SampleManager, LabVantage).
- Hands-on experience with LIMS implementations, configurations, validation (CSV/CSA), and user requirement gathering.
- Understanding of laboratory workflows across R&D, QA/QC, and regulated manufacturing environments.
- Familiarity with 21 CFR Part 11, GxP, ALCOA+ principles, and related compliance frameworks.
- Strong communication and project leadership skills in client-facing consulting environments.
Nice-to-Have Skills:
- Exposure to integration with ELN, CDS, SDMS, ERP, or cloud-based informatics ecosystems.
- Knowledge of data standards (e.g., Allotrope, AnIML) and lab automation/robotics integration.
- Experience with Agile delivery models and digital quality labs or smart factory initiatives.
- Technical familiarity with interfacing lab instruments using OPC, REST APIs, or middleware solutions.
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