Senior CMC Technical Advisor

About the role

The U.S. Pharmacopeial Convention (USP) is seeking a Senior CMC Technical Advisor to strengthen the supply of quality‑assured essential medical products. In this senior position you will provide technical assistance and oversight to manufacturers and regulators, helping to expand competencies in medical product manufacturing.

Key responsibilities

• Lead GMP audits and provide technical assistance to manufacturers on technology transfer and dossier development.
• Interface with internal USP departments, manufacturers of medical products, and regulatory authorities.
• Support the creation and implementation of public standards and related programs that increase global access to high‑quality medicines.

Required profile

• Senior‑level professional with extensive experience in CMC (Chemistry, Manufacturing, and Controls) for medical products.
• Proven ability to work with manufacturers and regulators to achieve quality‑assured outcomes.
• Strong collaborative skills to engage with internal and external stakeholders.

Required skills

• GMP audit execution
• Technology transfer expertise
• Dossier development and review

What we offer

• Opportunity to impact global public health through scientific standards.
• Inclusive and collaborative work environment with professional development resources.