Senior CMC Technical Advisor

About the role

USP is seeking a Senior CMC Technical Advisor to strengthen competencies in medical products manufacturing. The role provides technical assistance and oversight to manufacturers and regulators, helping to increase the supply of quality‑assured essential medical products worldwide.

Key responsibilities

• Lead GMP audits and support manufacturers during technology transfer activities.
• Review and guide the preparation of regulatory dossiers for medical products.
• Collaborate with internal USP departments, external manufacturers, and regulatory agencies.
• Provide expert advice on CMC (Chemistry, Manufacturing, and Controls) matters to ensure compliance with global standards.
• Contribute to the development and maintenance of USP public standards and related programs.

Required profile

• Extensive experience in pharmaceutical manufacturing and regulatory affairs.
• Proven ability to work with diverse stakeholders across different regions.
• Strong analytical and problem‑solving skills with a commitment to scientific integrity.
• Excellent communication skills in English.

Required skills

• GMP audit execution
• Technology transfer support
• Dossier preparation and review
• Regulatory compliance expertise

What we offer

• Opportunity to impact global public health through high‑quality standards.
• Inclusive and collaborative work environment.
• Professional development and leadership training.