Pharma R&D Functional SME

Role Overview

This position involves leading application management services (AMS) assessments, designing solutions, supporting proposals, and ensuring delivery quality within the Life Sciences domain.

Key Responsibilities

• Analyze portfolios and conduct workshops for solution development.
• Create solution designs and estimation models.
• Evaluate vendors and rationalize applications.
• Manage stakeholders and develop transformation roadmaps.

Domain & Platforms

Expertise spans Pharma R&D, Labs, Clinical, Manufacturing, Quality, Regulatory, TechOps, Commercial, and enterprise integrations.

Mandatory knowledge in platforms including Discovery, Preclinical, Lab Informatics, ELN, LIMS, GeneData, Benchling, BIOVIA, and Revvity.

Proposal Responsibilities

• Assess application inventories and map criticality.
• Define support models and plan transitions.
• Estimate efforts with SLA/KPI frameworks.
• Recommend modernizations and assess risks.

Regulatory & Compliance

• Understand and ensure adherence to GxP, GAMP5, 21 CFR Part 11, Annex 11.
• Maintain data integrity, computer system validation (CSV), audit readiness, and validation lifecycle awareness.

Qualifications & Skills

• Bachelor's or Master's degree in Engineering, Pharmacy, Biotechnology, Life Sciences, or equivalent.
• Substantial Pharma domain experience with excellent stakeholder communication.
• Preferred: global delivery experience, Agile/SAFe methodologies, cloud platforms, AI/Data knowledge, and related platform certifications.