Senior Advanced Manufacturing Technologies Manager ?
Rockville, MD • ID: 26436035 •
The Senior Advanced Manufacturing Technologies Manager is a key
technical position within USP’s Global Health and Manufacturing
Services (GHMS) Division. The position is responsible for the
development and implementation of technical strategies necessary
for achieving and maintaining current Good Manufacturing Practices
(cGMP) compliance for manufacturers using Advanced Manufacturing
Technology (AMT) processes and systems. The work of the Senior AMT
Manager focuses on supporting manufacturers through the
USAID-funded Promoting the Quality of Medicines Plus (PQM+) program
(approximately 75%). The balance of the Senior AMT Manager’s work
focuses on implementation of AMT practices and services for
manufactures across USP outside of the scope of PQM+.
Senior AMT Manager reports to the Vice President for
Manufacturing Services and belongs to the GMP/CMC functional team
of the PQM+ Program. The position works with PQM+ GMP/CMC experts
to accomplish the objectives of the PQM+ program in support of the
development and manufacturing of quality-assured priority essential
medicines for USAID-supported public health programs. The incumbent
also belongs to the PQM+ center of excellence for product supply
and supports the Technical Director in providing oversight of
global implementation of activities related to the program’s
objective of increasing the supply of quality-assured, essential
medical products. The Sr. Technical Advisor will be responsible for
identifying and driving innovation to support market development,
adoption and scale up of breakthrough yet appropriate manufacturing
innovations and technologies (e.g., continuous manufacturing) for
priority essential medicines in low and middle – income countries.
He/she will partner and collaborate directly with manufacturers,
government regulators & policy makers and development partners to
build market structures that will support local pharmaceutical
Roles and Responsibilities Evaluates and delivers technical AMT
solutions that have potential to improve the resilience of the
supply chain for quality medicines, including manufacture of
pharmaceutical products, access to quality pharmaceutical products,
and the patient experience with pharmaceutical products.
Leads projects to introduce innovative technology and/or improve
manufacturing robustness for USP clients
Collaborate with the Manufacturing Services team to develop
USP’s expertise in AMT and supporting solutions to deliver to USP
Provide thought leadership internally and externally on new and
emerging manufacturing technologies.
Propose strategies and mechanisms to shape new market structures
that accelerate adoption and technology transfer of commercialized
pharmaceutical solutions to low and middle- income countries with a
focus on AMT.
Identify and document incentives, disincentives, and any other
barriers to market development and adoption by pharmaceutical
Provide strategic analysis and insight on the market landscape,
dynamics & segmentation (including market sizing, trends, and
likelihood of early adopters of new technologies.
Will lead in engaging private sector actors to facilitate
public-private collaborations that support local manufacturing of
quality medical products.
Collaborate with other PQM+ GMP/CMC experts to lead the
development of strategies, approaches, and tools for the deployment
of PQM+ technical assistance to manufacturers to achieve
international quality standards including World Health Organization
Proactively identifies and advise on opportunities for
addressing supply concerns in TB, HIV/ AIDS, Malaria, NTDs, MNCH
and other areas.
Works closely with PQM+ Health Elements managers to understand
the latest treatment guidelines and the impact on PQM+
Liaise with the PQM+ Regulatory Systems Strengthening Team to
provide technical assistance to regulatory authorities and
Inspectorate toward the development of risk-based inspection
quality assurance and good practices inspection support to PQM’s
partners, stakeholders, and clients.
Review and provide timely inputs into key project deliverables
including work plans and reports (e.g., technical and donor
Actively contributes to annual programmatic and resource
planning process and to the development of quarterly and annual
reports of the PQM+ program.
Interfaces regularly with external stakeholders/ groups in
relevant areas including, with WHO pre-qualification team, Global
Drug Facility, and other key work groups Other duties as
Basic Qualifications Master's degree in pharmaceutical science,
chemistry, or public health required
At least 5 years experience of pharmaceutical sector working
with manufacturers in low-to-middle income countries, leading or
implementing technical assistance programs in expanding access to
global health products and pharmaceuticals
Demonstrated thought leadership and technical expertise advanced
manufacturing technologies in the pharmaceutical industry
Experience in current Good Manufacturing Practices (cGMP)
Direct experience with and understanding of WHO
Strong written and oral communication skills, including
technical writing and presenting.
Preferred Qualifications Willingness to travel at least 25% of
the time both domestically and internationally.
Experience in at least one of the following health areas: HIV/
AIDS, malaria, TB, NTDs, MNCH
Work experience in both Asia and Africa
Direct experience implementing USAID-funded programs
Understanding of global dynamics impacting the supply of
quality-assured pharmaceuticals and medical products
Fluency in French
USP offers an impressive benefits package , including:
Generous paid time off – 15 paid holidays, 10 sick days and 15
vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of
service, of 10% of pay (base and bonus) every pay period that vests
Comprehensive individual and family healthcare plans with
affordable premiums and low annual deductibles ($250/individual or
The U.S. Pharmacopeial Convention (USP) is a scientific
nonprofit organization that sets standards for the identity,
strength, quality, and purity of medicines, food ingredients, and
dietary supplements manufactured, distributed and consumed
worldwide. USP’s drug standards are enforceable in the United
States by the Food and Drug Administration, and these standards are
used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up
of more than 1,000 talented professionals working together at five
international locations. We share our expertise in science, IT,
human resources, quality assurance, communications, administrative
management, and more...all to support an overall mission dedicated
to making a difference by providing standards and programs that
help improve the quality of medicines, dietary supplements, and
USP is proud to be an equal employment opportunity employer
(EEOE) and affirmative action employer. Employment selection and
related decisions are made without regard to sex, race, age,
disability, religion, national origin, color, veteran status,
sexual orientation, gender identity or any other protected class.
We are committed to working with and providing reasonable
accommodation to individuals with disabilities.
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.