USP is seeking a Senior CMC Advisor based in India who will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products. The incumbent will interface with internal USP departments as well as manufacturers of medical products and regulators.
This consultancy has a period of performance from January 2026 – October 2028
Roles and Responsibilities· Lead technical assistance in advanced formulation development for complex products, including complex generics and
complementary supplements. Drive innovation in formulation strategies, technology transfer, and dossier preparation to ensure compliance with
international quality standards.
· Serve as the primary subject matter expert on formulation science, guiding manufacturers through feasibility studies, stability programs, and optimization of formulations for commercialization.
· Support manufacturers to accelerate development, the approval and commercialization of critical medicines
· Supports the USP CMC team to develop technical various documents and tools
· Support GMP audits and provide technical assistance to manufacturers on technology transfer, dossier development, and compliance with PIC/S, and EC standards through deployment of best-practice tools.
· Identify CMC risks and design mitigation strategies and contingency plans to ensure project continuity.
· Review and provide timely, high-quality input on technical deliverables and donor reports to ensure accuracy and compliance.
Basic Qualifications· Perform additional CMC-related tasks assigned by leadership to support program objectives.
· Minimum of 10 years of hands-on experience in pharmaceutical manufacturing and process development
· Proven expertise in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and preparation of regulatory submissions
· In-depth knowledge of WHO PQ, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards
· Comprehensive understanding of CMC principles and GMP requirements for medicines, packaging, and related areas
· Demonstrated experience navigating regulatory authority registration processes
· Exceptional technical writing and oral communication skills, with ability to produce high-quality documentation
· Willingness and Ability to travel up to 10% of the time
Preferred Qualifications· Practical experience with critical manufacturing systems and processes, including water systems, sterility assurance, HVAC, contamination
control, analytical chemistry, cleaning validation, and formulation development
· Strong understanding of global market dynamics and supply chain challenges affecting
access to quality-assured pharmaceuticals and medical products
Application Procedure:
Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org,
by the closing date of January 23, 2026. When submitting your applications, please write “CMC Senior Technical Advisor” in the email
Subject Line of your email.
About US Pharmacopeia
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop
quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. Our programs have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
This project, funded by the Gates Foundation, aims to expand access to quality, affordable multiple micronutrient supplements (MMS) for women in low- and middle-income countries. The goal is to strengthen and accelerate local manufacturing capacity in LMICs to produce United Nations International
Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS in line with international quality standards. By supporting manufacturers to meet global
regulatory requirements and optimize production processes, the project will contribute to increasing sustainable supply at scale and reducing at affordable price.
