Peptide Manufacturing Consultant

About the role

Vitals is expanding into peptide therapeutics and seeks a senior consultant to lead the technical planning, compliance and operational development of a new peptide R&D and pilot GMP manufacturing facility in Thailand. The role involves designing scalable manufacturing processes, sterile fill‑finish capabilities and supporting regulatory readiness.

Key responsibilities

• Lead the planning and setup of a peptide R&D and pilot GMP facility, including layout and workflow design.
• Advise on sterile fill‑finish capabilities for injectable peptides and cartridge/pen delivery systems.
• Select machinery, vendors and manufacturing partners; support cleanroom and HVAC design.
• Develop manufacturing SOPs, quality systems and GMP procedures; guide process validation and scale‑up.
• Provide regulatory guidance for Thai FDA compliance, global pathways and export readiness.
• Assist senior management with phased manufacturing strategy and make‑vs‑partner decisions.

Required profile

• 7+ years experience in pharmaceutical, peptide, biologics or injectable manufacturing.
• Hands‑on experience building or operating GMP facilities internationally.
• Strong knowledge of sterile manufacturing, aseptic processes and peptide synthesis (SPPS preferred).
• Familiarity with FDA, EMA, PIC/S and Thai FDA GMP requirements.

Required skills

• Peptide manufacturing
• Sterile injectables
• GMP operations
• Cleanroom/facility setup
• Cartridge and injectable pen systems
• Regulatory compliance (Thai FDA, FDA, EMA, PIC/S)
• Solid‑phase peptide synthesis (SPPS)
• Process validation
• Quality systems and SOP development