Senior CMC Technical Advisor

About the role

USP is seeking a Senior CMC Technical Advisor to provide technical assistance and oversight to manufacturers and regulators, helping increase the supply of quality‑assured essential medical products. The role will involve collaboration with internal USP teams, external manufacturers, and regulatory authorities.

Key responsibilities

• Lead GMP audits and assess compliance of manufacturing sites.
• Provide technical assistance on technology transfer and support the preparation of regulatory dossiers.
• Interface with internal USP departments, manufacturers of medical products, and regulatory agencies.
• Contribute to the development and implementation of USP standards and programs related to medical product manufacturing.

Required profile

• Senior‑level professional with extensive experience in CMC and medical product manufacturing.
• Strong knowledge of Good Manufacturing Practice (GMP) regulations and regulatory requirements.
• Proven ability to work with diverse stakeholders, including manufacturers and regulators.

Required skills

• Good Manufacturing Practice (GMP) auditing.
• Technology transfer expertise.
• Regulatory dossier preparation.

What we offer

• Opportunity to impact global health by improving access to high‑quality medicines.
• Inclusive and collaborative work environment with professional development support.