The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance. For more information, please visit: http://www.clintonhealthaccess.org

Overview of Team:

CHAI's Process Chemistry Team (PCT) provides a rare, transformative opportunity to help provide lifesaving drugs to millions of people in low-middle-income countries. The PCT was founded early in CHAI’s mission to add technical credibility to price negotiations with generic partners and to focus negotiation efforts on rational antiretroviral (ARV) drug targets. Since its inception, PCT has played a critical role in transforming the process chemistry of drugs by finding more cost-effective ways to manufacture lifesaving drugs; and in doing so, demonstrating that cost of goods can be dramatically reduced.

The group works on products that are in under development as well as products that have already been commercialized. Our team is able to achieve this by conducting detailed literature and patent analyses of relevant but more advanced manufacturing processes, using this knowledge to perform process chemistry research to optimize active pharmaceutical ingredients (API) manufacturing in CHAI’s laboratory as well as networking with industrial and academic collaborators to advance our work.

Through our work, the team has opened the opportunity for essential medicines to be accessible in low-middle-income countries and save millions of lives.

Overview of Role:

The Principal Scientist will work with the PCT Director and CHAI disease and technical leads to agree on a portfolio of drug products that will have substantial markets and whose chemistries are excellent candidates for optimization. For each of these drug candidates, the Principal Scientist will then design and implement process chemistry optimization strategies in the lab that will be simpler, safety, greener, less expensive, and based on readily available and high-quality raw materials. Critical to the success of our work is to ensure these approaches are highly scalable and these capabilities are transferred to quality manufacturers.

The Principal Scientist will also collaborate with CHAI partners (both in academic and non-academic settings) and engage with innovator and generic manufacturers in India, China and Africa. This position also supports good manufacturing practices (GMP) of clinical trial material and the development of long-acting formulations of drugs. Finally, this role provides a cornerstone of CHAI's work to ensure that better, high-quality, lower-cost products are available to more people who need care.

This role is based in Newark, Delaware, United States.

• Develop scalable synthetic processes to reduce costs of drugs of interest
• Set up and perform multiple experiments. Use lab equipment for reaction, distillations, re-crystallizations. Etc. Ensure the laboratory and equipment are maintained and cleaned
• Search out and place purchase orders for intermediates, solvents and chemical supplies
• Ability and desire to work in the laboratory is essential
• Develop and run analytical methods to test outcome of experiments. Analyze samples by NMR, HPLC, MS and GC
• Document the outcome of lab work in technical papers and reports. Communication and transfer of results to manufacturers and to partners
• Maintain instruments and equipment. Troubleshoot issues when they arise
• Assessment of potential manufacturers and contract research organizations involved in CHAI's research and development efforts
• Partner with academic groups and NGOs to advance global health through the development of better, safer, and less expensive medicines
• Contribute to CHAI and CHAI's Global Health Sciences department, including providing advice to other teams and CHAI collaborations, supporting the department’s fund raising and grant writing activities, and support for various product initiatives
• Additional responsibilities as requested by supervisor.

• PhD in synthetic organic chemistry is preferred
• More than 10 years of experience in process chemistry in a pharmaceutical industrial setting
• Recent experience with GMPs at lab scale and a deep understanding of the changing regulatory requirements for APIs and the finished products throughout development are essential
• Evidence of a high level of accomplishments as demonstrated by publications, patents, successful drug launches and career progression
• Ability to use and maintain analytical instruments typical of an organic lab
• Able to communicate, both oral and written, with diverse teams
• Familiarity with Microsoft suite of programs
• Entrepreneurial mindset, including ability to work independently, self-motivate, and propose and implement new initiatives
• Ability to be effective in high-pressure situations, handle multiple tasks simultaneously, and set priorities
• Detail-oriented with strong organization skills

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