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Director, Biologics Strategic Operations

United States Pharmacopeia
Rockville, MD
Start date
May 23, 2023

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Job Details


Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts 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 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

The Director, Biologics Strategic Operations will be responsible for the overall leadership of the program and project management function within the Global Biologics Department. This includes providing oversight of all project activity in the department: managing the Biologics project portfolio; the collection, prioritization, launching, tracking, and closure of projects. Additionally, the incumbent creates and maintains a uniform approach to project management and serves as change agent for continuous improvement through enhanced methodologies. The Director is responsible for planning, organizing, and directing designated strategic activities as well as providing project management oversight of designated scientific business unit initiatives. He/ She will mentor direct reports and manages performance, creates, and monitors budgets, designs and implements process improvement activities.

How will YOU create impact here at USP?

The Director has a key and strategic operating role to the organization leadership and plays an important role in the achievement of the overall success of USPs processes, procedures, and infrastructure. The roles and responsibilities are described herein:

Develop and maintain strong, collaborative relationships with key stakeholders and senior leadership in the relevant functional areas, to ensure clear alignment, and performance monitoring.

Build mechanisms to support transparency into the biologics portfolio to ensure appropriate focus on critical activities that align with the organization strategy and objectives.

Provide leadership, training, and direction to the project leaders who will be responsible for managing projects within the scientific groups.

Establish key project metrics to enable accurate project, financial and portfolio analyses to ensure accurate inputs are provided into business planning processes.

Ensure the project leaders have a solid understanding of project management methodology, including the ability to identify and manage risk, develop detailed work plans, manage budgets, report on key project metrics, and manage project teams effectively.

Drive continuous improvements in Project Management (efficiencies, consistency, and delivery).

Develop process and procedures to optimize project resources and expertise. Resolve resource conflicts among divisional projects.

Provide leadership for change management, and process improvement initiatives within Global Biologics. Facilitate lessons learned and recommend and implement new standards for the department.

Anticipate project issues; business, technical, and regulatory, and recommend project, process, or product improvements that address project issues or emerging risk.

Collaborate with partners from global functional areas, to ensure delivery of key project team activities against critical strategic objectives. Ensure timely completion and quality of project deliverables while working within product development budget allocations.

Drive resolution of any project issues (e.g., potential delays) and risks and engage the project sponsors to drive resolution as needed.

Provide the VP, Global Biologics an aggregate view of all Global Biologics project status, timelines, and risks.

May, with limited management oversight, lead other department initiatives including, but not limited to portfolio project management process refinement/development, new scientific technology solutions and/or product development initiatives.

Who USP is 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:

Masters degree in a science-based discipline required. 10 plus years of experience in product development in pharmaceuticals, biotechnology, or in life science industries.

Minimum of 4 years of experience supervising, leading teams, and mentoring staff members.

Minimum of 5 years of experience in project management including managing multiple, large, complex, and cross functional projects.

Proven project portfolio management experience.

Experience reporting key portfolio metrics to executive management.

Must be able to simultaneously focus on big picture, details and driving results.

Demonstrated ability to communicate complex ideas clearly and concisely.

Demonstrated ability to translate strategy into action.

Strong influence, negotiation, and presentation skills.

Additional Desired Preferences

Understanding of USP standards-setting processes and compendial terminology.

Knowledge of global pharmaceutical and healthcare industries and related trade associations.

Excellent ability to interface with senior leaders within client organizations.

Ability to solve complex discipline-wide problems with keen instincts and organizational experience.

Proven ability to develop project management practices for a scientific organization.

Demonstrated proficiency with project management practices, tools, and methodology.

Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.

Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.

Excellent analytical skills, with an ability to communicate complex issues in a simple way.

PMP certification preferred.

Supervisory Responsibilities

Supervises at team of 3 members, that include roles in program and project management.


USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

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 workfrom the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, 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.

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 Chemistry & Scientific Standards

Job Type Full-Time


USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. We do this through establishing public scientific standards and programs that help ensure billons of people around the world have access to safe and quality products.

USP aspires to be a diverse, inclusive, innovative, and engaging organization that empowers and engages staff and volunteers to contribute to its mission to improve global health. We are committed to creating a culture where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, family status, and where they can contribute their full potential to accomplish our mission.

At USP, you’ll join a talented and diverse team of 1,200 scientific, technical and public health professions, working in state-of-the-art facilities and collaborating with the world’s leading experts from industry, academia, healthcare, and government to address public health challenges and advance cutting-edge innovation.

Whether you’re helping to establish new USP standards, creating key resources to address emerging health issues, or providing critical technical assistance in the developing countries, you’ll be inspired by the positive impact your work has on building public trust and a healthier tomorrow.

Find Us
12601 Twinbrook Parkway
United States

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