Director, AMT Biologics Programs

Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, 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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.

Brief Job Overview
The USP Advanced Manufacturing Technologies team assists organizations considering the adoption of advanced manufacturing by addressing technical, knowledge, and training barriers through quality focused solutions. Advanced manufacturing technologies (AMT) include innovative approaches in both small molecules and biologics such as continuous manufacturing (CM), advanced manufacturing platforms, novel dosage forms, novel unit operations, etc.

The Director, AMT Biologics Programs is responsible for the development and coordination of the USP AMT Biologics strategy with a focus on bringing a wide variety of solutions to pain points across the industry and the US Government. The individual in this role will report to the Vice President, Advanced Manufacturing Technologies and will partner with other USP business leaders and organizations, including Pharmatech Associates, Global Biologics, and Global and Federal Practice, to coordinate companywide AMT Biologics efforts. Finally, the incumbent will identify and develop partnerships with external organizations and coalitions to extend reach and impact.

How will YOU create impact here at USP?
In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Director for AMT Biologics Programs has the following responsibilities:

• [30 %] Oversee the development of the USP AMT Biologics strategy in consultation and collaboration with Global Biologics and Global and Federal Practice teams.
  o Identify those areas where USP has an opportunity to meaningfully contribute IP that will facilitate the adoption AMTs in the biopharmaceutical industry.
  o Align the organization in support of discrete initiatives that build USP AMT Biologics-related IP, capabilities, reputation, and share of voice.
  o Coordinate and integrate the broad portfolio of USP AMT Biologics-related initiatives.
  o Identify opportunities to develop written and physical standards to support AMT for biologics in collaboration with the Global Biologics team.
• [20 %] Support the execution of specific high-impact USP AMT Biologics-related initiatives.
  o Work with business leaders to define initiative objectives, activities, and key milestones.
  o Provide thought leadership to project leaders and teams.
  o Identify risks and issues for direct resolution or escalation.
• [20 %] Maintain AMT Biologics situational awareness and build USP’s reputation among the biopharmaceutical community.
  o Ensure USP active participation in relevant forums.
  o Utilize USP convening power to engage stakeholders in value-adding dialogs.
  o Ensure that USP-developed AMT Biologics IP is timely and effectively disseminated widely to the biopharmaceutical community.
• [30 %] Build and execute on an AMT Biologics par