Senior Advanced Manufacturing Technologies Manager

Company: The United States Pharmacopeial Convention
Location: Rockville
Posted on: September 13, 2020

Job Description:

Senior Advanced Manufacturing Technologies Manager ? Scientific

Rockville, MD  •  ID: 26436035  •  Full-Time/Regular

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 manufacturing.

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 customers.

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 manufacturers.

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 (WHO) prequalification.

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+ manufacturing activities.

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 reports);

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 assigned.

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 pre-qualification process

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

PhD preferred

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 immediately

Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)

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 foods worldwide.

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.

Keywords: The United States Pharmacopeial Convention, Rockville , Senior Advanced Manufacturing Technologies Manager, Other , Rockville, Maryland