Job Title: Project Technical Lead GMP Peptide API Facility (SPPS)
Location: UAE
Industry: Pharmaceuticals / API Manufacturing
Experience: 8+ Years
About the Role
We are hiring for a Project Technical Lead GMP Peptide API Facility (SPPS) for a strategic greenfield project in the UAE. This role will act as the single-point technical authority for peptide drug substance manufacturing, leading the setup and operationalization of a world-class GMP-compliant facility.
Key Responsibilities
- Lead end-to-end design and setup of GMP peptide API manufacturing facility
- Oversee SPPS (Fmoc-based) synthesis, purification, and lyophilization systems
- Drive process development, scale-up, and technology transfer from existing sites to the UAE facility
- Ensure compliance with ICH Q7, EU GMP Part II, and global regulatory standards
- Support regulatory inspections, audits, and ensure overall audit readiness
- Oversee validation activities including IQ/OQ/PQ, process validation, and cleaning validation
- Build and lead a high-performing technical and operations team
- Manage global vendors, consultants, and cross-functional stakeholders
- Act as the primary technical interface for all project-related activities
Key Requirements
- PhD or MSc in Chemistry, Pharmaceutical Sciences, or related field
- Minimum 8+ years of experience in peptide manufacturing (SPPS)
- At least 5+ years of experience in GMP API manufacturing environments
- Strong expertise in Fmoc-based solid-phase peptide synthesis
- Proven experience in greenfield facility setup is highly preferred
- In-depth knowledge of global regulatory standards (ICH, EU GMP, etc.)
- Strong leadership, project management, and stakeholder management skills
Preferred Background
- Candidates from leading peptide/API organizations or global CDMOs
- Experience working with international regulatory bodies and inspections
- Exposure to large-scale peptide manufacturing and technology transfers
Application
Interested candidates can share their profiles at: [Confidential Information]
