Senior Business Analyst, Pharma ManufacturingMulti-Modality, CMO Op

The role

Be the digital and data bridge between our manufacturing organisation and our global network of Contract Manufacturing Organisations across small molecule (API, oral solid dose, semi-solids) and large molecule operations including biologics and cell & gene therapy. You'll own the digital side of a partner relationship end to end: onboarding and tech transfer, building the data connections, keeping them GxP-compliant, and delivering the analytics that come out of them. This is a science-first BA role — you'll need to understand the manufacturing process, not just write requirements about it.

Responsibilities

• Own the digital connection lifecycle for assigned contract manufacturing partners, from onboarding and tech transfer through to commercial supply.
  • Define ETL requirements, data mapping rules and integration protocols during tech transfer.
  • Design and manage data pipelines linking internal SAP S/4HANA, MES and LIMS with partner systems.
  • Drive alignment between small molecule and large molecule data ecosystems — consistent data models, time-series manufacturing data and quality metrics across both.
  • Work with data engineering teams to build and sustain a unified R&D and Manufacturing data ecosystem serving both modalities.
  • Act as the IT/OT business partner for your assigned partners — steering committees, Tier 2/3 operational governance, escalation management.
  • Ensure every solution and data exchange meets GxP, GAMP 5, FDA 21 CFR Part 11 and global data integrity expectations; support Computer System Validation activities alongside QA and Validation teams.
  • Run gap analyses to identify and close compliance risks across the external manufacturing network.
  • Elicit and document business and functional requirements (BRD/FRD, user stories) across R&D, Manufacturing, Quality and Supply Chain.
  • Translate scientific and manufacturing workflows — from development through commercial manufacturing — into technical specifications.
  • Plan and execute SIT/UAT.
  • Build Power BI dashboards on manufacturing and supply chain data to support S&OP and business development.
  • Build financial models supporting partner selection, pricing proposals and cost optimisation across the portfolio.

Preferred candidate profile - Experience
• 5–8 years as a Business Analyst, Systems Analyst or IT/OT liaison in the pharmaceutical or biotechnology industry.
• Hands-on experience managing digital integrations and data exchanges with external CMOs/CDMOs.
• Exposure to both small molecule and large molecule (biologics) development and manufacturing — strongly preferred.

Technical
• Working knowledge of SAP S/4HANA, MES and LIMS in a manufacturing context.
• Strong understanding of ETL processes, API management and time-series manufacturing data.
• Proficiency in SQL, data modelling and visualisation tools (Power BI, Tableau).
• Familiarity with data formats and standards used in pharma supply chains (XML, EDI, GS1).
• SAP ATTP for serialisation / track-and-trace is a strong plus.

Domain & regulatory
• Solid grounding in GxP, GAMP 5, FDA 21 CFR Part 11 and Computer System Validation methodologies.
• Familiarity with drug discovery and development workflows for both chemical and biological entities.

Education
• Master's degree in a life science discipline (Chemistry, Biochemistry, Biology, Pharmaceutical Sciences), Engineering, Computer Science or a related STEM field.
• MBA with a strong science undergraduate background also considered.

Also valued
• Cell & gene therapy or other emerging modalities.
• Large-scale digital transformation programmes (Industry 4.0, smart manufacturing).
• CBAP, PMI-PBA, CSM or SAFe certification.
• Cloud data platforms (AWS, Azure, GCP) and big data technologies.

Working style
• Strong stakeholder management — able to bridge scientific, operational and IT teams.
• Proven vendor and partner relationship management in a global setting.
• Comfortable in Agile/Scrum delivery.

Perks and benefits - • Fully remote — work from anywhere in India
• Flexible working hours; no fixed shift or mandated log-in times
• Outcome-based working — we care about delivery, not desk time