Director, CMC Technical
Location: Rockville
Posted on: June 23, 2025
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Job Description:
Description Who is USP? The U.S. Pharmacopeial Convention (USP)
is an independent scientific organization that collaborates with
the worlds leading health and science experts to develop rigorous
quality standards for medicines, dietary supplements, and food
ingredients. At USP, we believe that scientific excellence is
driven by a commitment to fairness, integrity, and global
collaboration. This belief is embedded in our core value of Passion
for Quality and is demonstrated through the contributions of more
than 1,300 professionals across twenty global locations, working to
strengthen the supply of safe, high-quality medicines worldwide. At
USP, we value inclusive scientific collaboration and recognize that
attracting diverse expertise strengthens our ability to develop
trusted public health standards. We foster an organizational
culture that supports equitable access to mentorship, professional
development, and leadership opportunities. Our partnerships,
standards, and research reflect our belief that ensuring broad
participation in scientific leadership results in stronger, more
impactful outcomes for global health. USP is proud to be an equal
employment opportunity employer (EEOE) and is committed to ensuring
fair, merit-based selection processes that enable the best
scientific mindsregardless of backgroundto contribute to advancing
public health solutions worldwide. We provide reasonable
accommodations to individuals with disabilities and uphold policies
that create an inclusive and collaborative work environment. Brief
Job Overview The CMC Technical Director is a key leadership
position within an anticipated donor-funded program, responsible
for the development and implementation of CMC and product supply
technical assistance activities across multiple countries in
Africa. As the Technical Director for this program, they will
provide strategic technical oversight and direction to all
implementation of activities related to the programs objective of
increasing the supply and access of quality-assured, essential
medical products, including provision of technical assistance to
manufacturers (including, GMP, Dossier development and submission,
business and commercialization planning), pharmaceutical sector
planning/development, product development, and technology transfer.
The Technical Director will lead a team of about 5-6 technical
staff and consultants involved in the implementation of CMC-focused
technical activities. They will also oversee the implementation of
activities by external partners on this opportunity. Additionally,
they act as a highly visible thought leader, interfacing with
global experts, partners, regional stakeholders, and leaders in
supply and manufacturing, and developing and disseminating new
content to advance global knowledge on sustainably increasing the
supply of essential medicines. How will YOU create impact here at
USP? As part of our mission to advance scientific rigor and public
health standards, you will play a vital role in increasing global
access to high-quality medicines through public standards and
related programs. USP prioritizes scientific integrity, regulatory
excellence, and evidence-based decision-making to ensure health
systems worldwide can rely on strong, tested, and globally relevant
quality standards. Additionally, USPs People and Culture division,
in partnership with the Equity Office, invests in leadership and
workforce development to equip all employees with the skills to
create high-performing, inclusive teams. This includes training in
equitable management practices and tools to promote engaged,
collaborative, and results-driven work environments. The CMC
Technical Director has the following responsibilities: Provide
leadership for the management and implementation of CMC-related
technical activities for a donor-funded project, in coordination
with the Project Director. Provide technical and strategic
leadership to technical experts (staff, consultants, manufacturers,
and multiple consortium partners) in manufacturing (including GMP,
Dossier development and submission, business and commercialization
planning), pharmaceutical sector planning /development, product
development, and technology transfer. Serve as key point of contact
with the donor for technical engagements, offering expert advice
and insights to advance the introduction of new and complex
pharmaceutical products as directed by the Project Director. Define
strategy and approach for technical assistance delivery across all
areas related to the supply of essential medicines and
manufacturing support, ensuring alignment with international
best-practices and with already defined USP technical approaches,
where relevant. Ensure consistent, high-quality, and results-driven
technical assistance provision for all activities under their
technical scope, identifying and delivering continuous improvements
based on new evidence / information, and programmatic experience.
Lead CMC work group, comprised of regional technical experts in
CMC, market intelligence experts, and key partners, directed to
help inform technical approach and continuous improvement. Work
closely with donors to proactively identify and advise on
opportunities to address supply concerns in HIV / AIDS, Malaria,
MNCH, and other areas as directed. Actively participate in a
cross-functional team to ensure the objectives of programs are
successfully met. Actively contribute to annual programmatic and
resource planning process and to the development of quarterly and
annual reports. Oversee resource deployment for their area, with
the objective of maximizing efficiency and impact and of
progressively developing staff and local/ regional partners. Act as
globally visible thought leader in area, actively advancing and
deploying relevant knowledge based on programmatic experience and
identified relevant research topics identified by donor externally
in relevant forums. Interfaces regularly with key global external
stakeholders/ groups in relevant areas including, with WHO
pre-qualification team, Global Drug Facility, procuring agencies,
and other key work groups. Who is USP 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 pharmaceutical science, chemistry, engineering
or science related field of study required; PhD strongly preferred.
Extensive [12 years] experience leading and implementing technical
assistance. programs in expanding access to global health products
and pharmaceuticals. Substantive [8 years] people management
experience and skills, including ability to seamlessly manage
virtual teams. Substantive [8 years] Pharmaceutical sector
experience including previous work experience with low-resource
setting country manufacturers. Substantive regulatory filling
experience including with but not limited to USFDA. Experience in
formulation development for finished pharmaceutical products.
Experience working or interacting with CDMOs. Understanding of
global dynamics impacting the supply of quality-assured
pharmaceuticals and medical products. Direct experience with or
understanding of WHO pre-qualification process. Working
understanding of Chemistry, Manufacturing and Controls and Good
Manufacturing Practices. Demonstrated thought leadership in areas
related to medical product access and supply. Strong written
(especially technical writing) and oral communication skills.
Willingness to travel at least 25% of the time. Additional Desired
Preferences Work experience in LMICs, preferably in Africa. Fluency
in French or Portuguese. Experience in at least one of the
following health areas: HIV/ AIDS, malaria, AMR, MNCH. Supervisory
Responsibilities Yes. This position will manage 3-4 direct reports,
including technical staff based in Africa, and will also oversee
and manage at least two external partners on a donor-funded
opportunity. Benefits USP provides the benefits to protect yourself
and your family today and tomorrow. From company-paid time off and
comprehensive healthcare options to retirement savings, you can
have peace of mind that your personal and financial well-being is
protected. Compensation Base Salary Range: USD $153,000.00
$203,500.00 annually. Target Annual Bonus: % Varies based on level
of role. Individual compensation packages are based on various
factors unique to each candidates skill set, experience,
qualifications, equity, and other job-related reasons. 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. Equal
Opportunity Employer/Protected Veterans/Individuals with
Disabilities This employer is required to notify all applicants of
their rights pursuant to federal employment laws. For further
information, please review the Know Your Rights
(https://www.eeoc.gov/poster) notice from the Department of Labor.
Job Category Technical Programs Job Type Full-Time
Keywords: , Arlington , Director, CMC Technical, Science, Research & Development , Rockville, Virginia