Chemical Development Director

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Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards formedicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality
medicines and supplements worldwide.

Brief Job Overview
The Director for Chemical Development is vital to the success of delivering new and innovative solutions to solve some of the most difficult supply chain challenges within the global Active Pharmaceutical Ingredient (API) and Key Starting Material (KSM) market. As a key member of USP’s Advanced Manufacturing technologies (AMT) team, the Director for Chemical Development will define and execute technical programs to build novel API/KSM processes and ensure effective technology transfer of those processes to local manufacturers, which includes extensive capability building for local manufactures and regulators. This role will directly support USP’s Global Public Health programs, including at inception the USAID PQM+ programs designed to build local pharmaceutical manufacturing capabilities in Central Asia (e.g., Kazakhstan and Uzbekistan).

How will YOU create impact here at USP?

• [20 %] Novel chemical process development and analytical methods
o Work with relevant technical and program delivery teams to develop and execute a
protocol for determining the technical feasibility of local production of specific APIs
and KSMs.
o Using your scientific creativity and the expertise at the USP Flow Chemistry
Laboratory in Hyderabad, India, the USP AMT Laboratory in Richmond, VA, and the
USP R&D Solutions Laboratory in Rockville, MD, oversee the development of new
synthetic pathways for specific API and KSM projects. This includes chemical
process design, optimization, implementation, and management of robust, cost
effective, and safe processes for the manufacture of small molecule APIs and KSMs.
o Leverage USP’s broad analytical method development capabilities to ensure that all
chemical processes developed are accompanied by validated analytical methods
suitable for technology transfer from laboratory scale to commercial scale.

• [50 %] Effective Technology Transfer and Knowledge Development - The scope of
the role encompasses a wide breadth of lifecycle, ranging from early-stage development,
late-stage development, process validation to commercial manufacturing.
o Execute a workforce development program using custom-built training, existing USP
training resources, and onsite training at the USP Flow Chemistry Laboratory to
upskill R&D chemists and manufacturing technologies to ensure technology transfer
is successful and long-lasting.

o Oversee the chemical process and analytical technology transfer from laboratory scale
to commercial scale manufacturers in local markets.

• [30 %] Building a better medicine cabinet for all. Identify new supply chain challenges – both global and regional - that can be solved with novel chemistry and intensified processes.
o Propose how USP can work with partners to solve those problems.
o Build the next program to solve and scale those solutions.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

• Master’s degree in synthetic organic chemistry, chemical engineering, or other relevant field plus 10 years of related experience.
• Alternatively, a Ph.D. in a relevant field and 7 years of experience or another combination of experience and education may substitute.
• Strong, mission-driven attitude to make meaningful changes affecting patients anywhere in the world.
• Demonstrated experience developing scalable, novel chemical processes.
• Demonstrated prior experience with process technology transfer from laboratory scale to commercial scale required.
• Willingness to travel domestically and internationally 25%.

Additional Desired Preferences:

• Skills to conduct technoeconomic analysis.
• Experience in process intensification.
• Strong communication skills.
• Experience working with local manufacturers in Asia.

Supervisory Responsibilities:

None.

Benefits:

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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