Vacancy: Formulation consultant for dispersible tablets technology

Company Profile

The U.S. Pharmacopeial Convention (USP) USA is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Job Description

USP was awarded the Promoting the Quality of Medicines Plus (PQM+), a USAID-funded global program designed to sustainably strengthen medical product quality assurance systems in low-and-middle income countries.  PQM+ is currently in its third year of implementation and is seeking to hire a consultant to develop a technical guide on Dispersible Tablet (DT) Delivery and Formulation Technology.  The technical guide will inform potential manufacturers on how to formulate, manufacture, test and ensure the safety, quality, and efficacy of DT products. The consultant will work under the guidance of the senior program manager for West Africa and in coordination with technical staff at USP headquarters in Rockville, MD. Consultant may provide additional support to other buy-ins in the subsequent program years. The period of performance for this consultancy will begin in June and run through September 30, 2022.

Roles and Responsibilities

• Serves as a technical resource among the PQM+ technical RSS consultant to develop a technical guide with all details necessary for a manufacturer to manufacture medicines with DT delivery technology.  Minimally, the guide should include details on:
  
  
  
  • DT technology and limitations
  
  
  • Developing formulations with various API types based on dispersion tablet technologies
  
  
  • Choosing excipients based on API properties
  
  
  • Considerations for processing equipment, conditions etc.
  
  
  • Formulating to meet disintegrating and other property specification requirements
  
  
  • Considerations for taste masking ingredients
  
  
  • Developing physical and chemical testing techniques that help to predict drug product behavior
  
  
  • Identifying materials, systems, formulations, and processes to meet product requirements
  
  
  • Setting up manufacturing facilities including all requirements (facilities, equipment, and personnel)
  
  
  • Setting up quality control laboratories including all requirements (facilities, equipment, and personnel)
  
  
  • Considerations for safety
  
  
  
  

• Participates in the development of in-house training programs to ensure sustainability and transfer of knowledge.


• Deliver training to manufacturers and regulatory personnel on DT delivery technologies


• Provide consistent, high-quality, and results-driven technical assistance provision for relevant activities identifying and delivering continuous improvements based on new evidence/ information and programmatic experience


• Flags technical project challenges, risks, and issues, elevating them to the Project Management Lead


• Report on all activities implemented under the specific project.


• Performs other assignments as requested by the senior program manager West Africa, Senior Technical Advisor, CMC, or the Senior Technical Director.

Required Skills or Experience

Basic Qualifications

• Bachelor of Science degree in Pharmacy, Pharmaceutics Science, Chemistry, Chemical Engineering or other related field of study or industry.


• 10 years of experience in pharmaceutical manufacturing and/or research and development


• Ability to work independently, as well as with cross-cultural and cross-functional teams

Skills Sought

• 5 years + hands-on experience in pharmaceutical tablet dispersion and formulation technology with various APIs


• Experience in drug pre-formulation /manufacturing


• Experience in the design, development, optimization, qualification, and analytical method transfer using various lab equipment’s.

Preferred Qualifications

• Demonstrated experience in pharmaceutical tablet dispersion and formulation technology with various APIs


• Experience working as a technical expert for a USAID-funded programs.