Director, AMT Biologics Programs

2 months ago

Rockville, United States United States Pharmacopeia Full time

Description

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 workan 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 USPs 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 partnership and funding portfolio.o Identify and secure the cooperation of key collaboration and/or funding partners (e.g., manufacturers, academic institutions, United States Government, venture capitalists, etc.).o Provide technical assistance to partners, customers, and funders to solve critical problems in the AMT Biologics community, where the need matches the individuals expertise.o Ensure the portfolio of partners and funders is robust and diverse.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: Bachelors degree and fifteen (15) years of related experience; masters degree and ten (10) years of related experience; or Ph.D. (or equivalent advanced degree) and five (5) years of related experience. Experience in pharmaceutical manufacturing and/or biopharmaceutical manufacturing. Active in the AMT community. Strong critical thinking and business acumen. Experience in program management and/or change management. Communications skills, confidence, and presence to engage effectively with senior executives and senior government officials. Comfort with ambiguity. Desire to affect change and drive public health impact.Additional Desired Preferences AMT-related background preferred. Ability to leverage a broad AMT-related network preferred. Experience with continuous manufacturing of biologics. Proven ability to execute through influence rather than authority desired.

Supervisory Responsibilities

None.

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.

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

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Technical Programs

Job Type Full-Time

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