Sridévi Ramanoudjame

Partner

  • PhD in therapeutic chemistry, Masters degree in Business Administration (Vlerick Business School, Belgium)
  • Expertise on Peptides DS and DP 
  • Wide ranges of leadership roles in Pharma/Biotech: DS, CMC, CMC Strategy, Supply chain, CMC-Regulatory strategy, Sustainable Operations and Supply Chains
  • International, cross-cultural project and relationship management services
  • Long-term or project-based, part-time lean and pragmatic consultancy model, ranging all the way from spot, arms-length support to integrated management missions in Tech Ops, QA areas, Regulatory CMC, Sustainability

2025-Present

Marble Pharma Consult SRL — Senior CMC Consultant (Brussels, Belgium)

  • Consultancy in the field of Peptides DS & DP (development, manufacturing, strategy, quality, regulatory, supply chain management, pre-MAA/NDA technical transfer lead)
  • Consultancy in the field of ADC (due diligence, quality audit, regulatory authorities interactions)
  • Vendor selection, quality audits and QAA/MSA/CSA contracts negotiations
  • Operational excellence and Lean operations implementation

2023-2025

BioNTech SE — Director CMC (Mainz, Germany)

  • CMC lead for pre-clinical/Ph I mAb & ADC program (DS, DP)
  • CMC lead for pre-clinical/Ph I preparation peptide-conjugates platform (DS, DP)
  • Peptide and Solid Phase Synthesis SME
  • SPOC for program-related external activities (EU/US/CN) with leading CDMOs: manufacturing, control strategy, CMC strategy, QC testing, stabilities, troubleshooting, supply chain, storage
  • Vendor selection and supplier qualification support: audits (DS: peptides, lipids, mAb, ADC) and DP (sterile lyophilized products), QAA/MSA support

2022-2023

Imcyse SA — CMC Project Coordinator and Manager (Liège, Belgium)

  • CMC Lead for DS (peptide) and DP (sterile injectable) for several pre-clinical, Ph I and Ph II clinical projects
  • CMC strategy deployment function to clinical phase including Phase III preparation
  • Single Point of Contact for external activities: manufacturing, CMC strategy, testing, stabilities, investigations, supply chain, storage
  • Vendor selection and supplier qualification support: audits (DS: peptides, lipids, mAb, ADC) and DP (sterile lyophilized and liquid products), QAA/MSA support

2020-2022

UCB Pharma SA — Peptide SME (Braine-l’Alleud, Belgium)

  • Authoring supporting documents for module 3.S NCE successful file submission (EU, JP, USA)
  • DS Lead: validation preparation, technical transfer, scale-up, process optimization, investigations (deviations, response to regulatory authorities, CMC strategy)

2020

PCBIS — Clinical Scientist (Illkirch-Graffenstaden, France)

Development and set-up of a safe methodology to analyze patient blood and serum samples to determine levels and clearance of a tested drug against COVID-19.