Project opportunity for Business Analyst | Europe | Remote - occasional travel
AMM ENTERPRISE GmbH
Contact person: Priya Badiger
madrid, Spain
Medicine and PharmaceuticalsAgile MethodologyAtlassian JiraBusiness AnalysisLaboratory Information Management SystemsPharmaceuticals
Description
Dear Candidate,
Please find the details below
Role: Business Analyst
Location: Europe | Remote - occasional travel
Mode: Freelance B2B contract
Language: English
JD
Responsibilities
? Elicit Instrument Integration Requirements: Collaborate with AD and QC laboratory personnel to catalog analytical instruments, identify raw data output formats (files, APIs, databases, serial outputs), and define automated ingestion triggers into the Tetra Data Platform.
? Design Data Harmonization Schemas: Partner with Data
Architects and Scientists to define requirements for Tetra Intermediate Data Schemas (IDS), standardizing raw analytical outputs into contextualized, vendor-agnostic data models ready for downstream analysis.
? Define End-to-End Scientific Workflows: Map data flows connecting Level 2 laboratory instruments to Level 3/4 enterprise systems, ensuring seamless ingestion into Electronic Lab Notebooks (ELN/Benchling), Laboratory Information Management Systems (LIMS), and Analytical Data Lakes.
Uphold GxP Data Integrity & Validation: Author user
requirements specifications (URS), functional design specifications (FDS), and traceability matrices. Partner with the Validation Expert to ensure all data pipelines, audit trails, and electronic signatures comply with 21 CFR Part 11, EU Annex 11, and ALCOA+ standards.
Drive Agile Product Delivery: Translate complex scientific and architectural requirements into user stories, process flows, and clear acceptance criteria; partner closely with the dedicated Tester and Tetra Integration Engineers during sprint execution.
Manage Cross-Functional Stakeholders: Bridge technical communication across laboratory operations, instrument vendors (e.g., Cytiva, Waters, Roche Diagnostics, Agilent), enterprise IT architecture, and digital quality assurance.
Candidate requirements:
Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
Experience with AP ALM, Jira and Agile way of working / delivery
- Good communication skills - fluent in written and spoken english. .
- Domain Expertise: Demonstrated experience working in pharmaceutical laboratories, specifically within Analytical Development (AD), Quality Control (QC), or Manufacturing
Science & Technology (MSAT). Experience in Cell and Gene Therapy (CGT) testing (e.g., cell viability, flow cytometry, ddPCR, potency assays) is preferred.
- Lab Informatics & Integration Platforms: Experience with the Tetra Data Platform (TDP) is a plus.
- Enterprise Lab Systems Knowledge: Familiarity with Level 3 lab ecosystems, including LIMS (e.g., LabWare, Benchling), Electronic
Lab Notebooks (ELN), Chromatography Data Systems (CDS - Empower), and Scientific Data Management Systems (SDMS).
- Data Modeling Understanding: Foundational knowledge of structured data formats (JSON, XML, CSV, Parquet) and the concept of data contextualization and schema mapping.
- Regulatory & GxP Compliance: Strong working knowledge of Computer System Validation (CSV / CSA), GAMP 5, 21 CFR Part 11, and data integrity principles for QC release environments.
If interested in this role, please share your CV to ***@***.com