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Head of Manufacturing Science & Technology (MS&T)

acino · Cairo

جديد
Senior 🇬🇧 English
Process validation Technology transfer Lean Six Sigma FDA EMA ICH GMP

وصف الوظيفة

About the role

Arcera, a global life sciences company developing, manufacturing and commercializing medicines, is looking for a Head of Manufacturing Science & Technology (MS&T) for its site in Al Obour City, Cairo. The role leads all MS&T activities at the site, ensures robust, compliant and efficient manufacturing across the product lifecycle, and reports to the Site Head. It acts as the site MS&T authority and strategic partner to Manufacturing, Quality, Supply Chain, Regulatory and Global MS&T teams.

Key responsibilities

  • Lead and implement the site MS&T strategy in line with global and regional TechOps objectives, and act as the single point of accountability for MS&T performance.
  • Lead technology transfer (internal and external), including scale-up, validation and commercialization, and own the process validation lifecycle (PPQ, CPV, revalidation) under FDA, EMA and ICH requirements.
  • Provide hands-on technical leadership to Manufacturing on troubleshooting complex process and quality issues, drive yield and cycle-time improvement, and lead root cause investigations.
  • Apply Lean, Six Sigma and Operational Excellence tools, and represent MS&T in audits, inspections and regulatory submissions.
  • Work with Quality, Regulatory Affairs, Supply Chain, Engineering, EHS and CMOs to keep processes aligned and compliant.
  • Ensure adherence to global MS&T standards, data integrity and GMP compliance, and contribute to global and regional MS&T communities of practice.

Required profile

  • Advanced degree (Master's or PhD preferred) in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology or a related field.
  • Minimum 12-15 years of experience in pharmaceutical manufacturing, MS&T or technical operations.
  • Proven experience in technology transfer, commercial manufacturing, process validation and regulatory inspections and compliance.
  • Experience in global and matrix organizations.
  • Fluent English is a must.

Required skills

  • Process validation and lifecycle management (PPQ, CPV, revalidation)
  • Knowledge of FDA, EMA and ICH standards
  • Lean, Six Sigma and Operational Excellence tools

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acino

Cairo