Part time CMC Senior Technical Advisor – India

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.

USP is seeking a part-time 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 consultant will interface with internal USP departments as well as manufacturers of medical products and regulators. Must be available on a part-time basis during normal work hours.

Period of Performance: Varied engagement over the July 2026–November 2028 period.

Anticipated Level of Effort (LOE) : approximately 25% (or 65 days out of one year) for the first year. LOE for following 2 years TBD.

Roles and Responsibilities

- Lead technical assistance in advanced oral solids formulation development for complex products, including complex generics and complementary supplements.



Drive innovation in formulation strategies, process development, 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 various technicaldocuments 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.
- Collaborate with cross-functional teams to design and implement manufacturing strategies that align with global best practices.
- Review and provide timely, high-quality input on technical deliverables and donor reports to ensure accuracy and compliance.
- Perform additional CMC-related tasks assigned by leadership to support program objectives.

Basic Qualifications
- Bachelor of Science degree in Pharmaceutical Sciences, Chemistry, Chemical engineering, or related scientific field with minimum of 15 years of relevant experience, or a Master’s degree with minimum 12 years of relevant experience, or a PhD degree with minimum 10 years of relevant experience.




- Proven expertise in GMP drug product development, particularly in solid oral dosage forms, manufacturing processes, process robustness and validation, root cause analysis, change control and deviation management, 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
- Demonstrated ability to apply the principles of physical pharmacy, physical/ organic chemistry, engineering and material science to solve practical pharmaceutical product development and manufacturing issues.
- Comprehensive understanding of CMC principles and GMP requirements for medicines, packaging, and related areas.
- Proven track record in operating in a fast-paced manufacturing environment to resolve technical issues.
- Experience with Tablet formulation.
- 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 [email protected] , by the closing date of August 8, 2026 . When submitting your applications, please write “ CMC Advisor - India ” in the Subject Line of your email.

📌 CMC Senior Technical Advisor (India)
🏢 US Pharmacopeia
📍 India