Call for Drug Formulation/Excipients Consultant
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) Drug Formulation/Excipients
USP seeks a Drug Formulation/Excipient expert to work with LMICs to provide guidance in formulating, facility design, manufacturing, and/or testing of drug products/excipients.
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 drug product formulation and excipients. The consultant will also serve as a technical resource for PQM+ to develop formulation details necessary for manufacturers to manufacture quality drug products with approved excipients.
Potential tasks/Responsibilities
The potential selected consultant will be responsible for:
· Documenting all technical aspects of drug product formulations and excipient selection.
o Determining API intrinsic properties and formulation needs to meet drug product performance targets
o Drug formulations
o Selecting excipients based on API properties
o Facility design
o Equipment selection
o Excipients and Drug Product Manufacturing
o Excipients and Drug Product Testing (QC lab set-up)
o Safety
· Developing validation protocols
· Write validation reports
· Provide training to ensure sustainability and transfer of knowledge
· Attend regular progress update meetings as required
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
· Knowledge and experience of Drug product formulation/excipient
· 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 pharmaceutical industry formulations
· Experience working with pharmaceutical drug excipients.
· Experience in drug product manufacturing
· Experience in drug pre-formulation /manufacturing
· Experience in manufacturing facility design, development, optimization, qualification, and analytical method transfer using various lab equipment’s.
· Experience in excipient and finished product testing.
Preferred Qualification
· Demonstrated expertise with either of the following as needed:
o oral solid dosage forms (general)
o tablets
o capsules
o gels
o liquids
o powders
o transdermal
o parenterals
· Demonstrated experience in pharmaceutical technology with various drug product formulating/excipients selection.
· Experience working as a technical expert for a USAID-funded program.
· Proven experience in drug product manufacturing, regulations, NRA, SRA and/or WHO drug product 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, deadline. When submitting your application, write “Call for Drug Formulation/Excipients Consultant” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify 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.
