Scope of Work
Consultancy Services for Active Pharmaceutical Ingredient (API) Manufacturing
USP seeks consultants/vendors with expertise in one or more of the technical areas of interest below to be shortlisted for a candidate pool for potential future work in various countries throughout the Africa, Asia, and Central Asia regions. Note that this is a general Call for Consultants to build a qualified applicant pool. This job posting does not guarantee employment. Consultants and firms who meet the outlined qualifications and skills listed below will be added to the USP Consultant Database for future potential engagement. Those selected to be added to the Consultant Database will be notified. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division. Applications may be made to one or more of the technical areas of interest, based on the consultant’s/vendor’s qualifications. Note that this is a remote role with possibility for travel. This is a global position and candidates worldwide are encouraged to apply. Note that this may be a remote position with possibility of travel.
TECHNICAL AREAS OF INTEREST
A) Active Pharmaceutical Ingredient (API) Manufacturing
USP seeks an API Manufacturing expert to work with manufacturers and National Regulatory Agencies (NRA) in LMICs to provide guidance in the synthesis, facility design, manufacturing, testing and characterization of APIs.
The consultant will lead this work with oversight and input from USP’s Global Health and Manufacturing Services (GHMS) and/or PQM+ technical advisors regarding all aspects of the API Manufacturing.
Potential tasks/Responsibilities
The selected consultant will be responsible for carrying out:
· Key starting materials selection
· Synthesis
· Scaling up
· Manufacturing facility design
· Manufacturing
· Testing (Purity and impurity)
· Characterization
· Document all technical aspects of the APIs manufacturing process
· Provide training.
· Attend regular progress update meetings as planned.
Basic Qualifications
· Bachelor of Science degree in Pharmacy, Pharmaceutics Science, Chemistry, Chemical Engineering or other related field of study or industry.
· 15 years+ of experience in pharmaceutical manufacturing and/or research and development
· Hands-on experience in API Manufacturing
· Ability to travel internationally for up to 25% of the time (if applicable)
· Ability to work independently, as well as with cross-cultural and cross-functional teams.
· Excellent written and oral communication skills, including experience in training and mentoring staff and others.
· Fluency in English is required. Fluency in other selected languages as required: French, Portuguese, Spanish, or Russian
Skills Sought
· 15 years + hands-on experience in the pharmaceutical industry with various APIs
· Hands-on experience with API synthesis and process scale-up
· Experience in API manufacturing facility design
· Experience in API testing
· Experience in API characterization
Preferred Qualification
· Demonstrated experience in pharmaceutical technology with various APIs.
· Experience working as a technical expert for a USAID-funded programs.
· Proven experience in API manufacturing, regulations, NRA, SRA and/or WHO API registration and GMP compliance requirements
· Experience in scientific research writing and publication.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to gph_procurement@usp.org by the May 08, 2024. When submitting your application, write “Call for API Manufacturing Consultant” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
