This position involves hands-on API synthesis at all phases of the project including bench synthesis, scale up and commercialization. The process chemist will devise experiments to optimize the manufacturing process to meet all target specifications. Once the API synthesis process is fully developed, scaled up and optimized, the individual will be responsible for drafting detailed standard operating procedures and performing syntheses to validate the manufacturing process.
Scope of Work
· PQM+ is seeking a process chemist consultant to:
o Provide hands-on API synthesis support.
o Design experiments leading to an optimized synthesis process.
o Develop specifications for raw materials, intermediates and final product.
o Carryout API synthesis.
§ Bench-scale API synthesis to demonstrate chemistry.
§ Optimize chemistry per target specifications e.g. yield, purity etc.
§ Scale up optimized synthesis to commercial scale.
§ Carry out synthesis of scaled pre-validation and validation batches.
o Develop standard operating procedures of optimized and scaled API synthesis processes.
o Develop process safety guidelines and perform safety risk assessments.
o Train other staff as necessary.
Qualifications
· Minimum o Bachelor’s degree in Chemistry, Chemical Engineering or related degree (advanced degree preferred)
· Minimum of 10 years of experience in process chemistry in an industrial setting including scaling up, optimizing, validating and commercializing syntheses (pharmaceutical preferred)
· Ability to communicate effectively with staff, internal and external stakeholders.
· Experience in statistics, design of experiments.
· Experience writing standard operating procedures and reports.
· Ability to work independently, as well as with cross-cultural and cross-functional teams.
· Willingness to travel to/from South Africa as required for technology transfer (Transferring site is located in the USA)
· Regular written progress updates on all activities undertaken during the previous activity period:
· Documented process improvements and/or Standard operating procedures
Please send CV, 3-References, and Hourly Rate in US$ to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of April 26,2024. When submitting your application, write “Process Chemist Consultant – PQM+ Core TB – South Africa in the email Subject Line.
The Promoting the Quality of Medicines Plus (PQM+) program[1] is a six-year (September 27, 2019 - September 26, 2025) U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to national regulatory authorities and health product manufacturers in a number of African and Asian countries.
PQM+ is currently assisting an active pharmaceutical ingredient (API) manufacturer in South Africa with technology transfer from a United States based organization. Technical assistance is required for technology transfer, scale up and commercialization of the API synthesis process. PQM+ seeks to hire a process chemist consultant to provide hands-on assistance in active pharmaceutical ingredient (API) synthesis from scale up through commercial scale manufacturing.
[1] https://www.usp.org/sites/default/files/usp/document/our-impact/pqm/pqm-plus-overview-brochure.pdf
