The U.S. Pharmacopeial Convention (USP) Senior Director, Growth Programs (Excipients, Foods, Dietary Supplements & Herbal Medicines) in Rockville, Maryland
Senior Director, Growth Programs (Excipients, Foods, Dietary Supplements & Herbal Medicines)
The Senior Director – Excipients, Foods, Dietary Supplements and Herbal Medicines, is a key leadership position in the Documentary Standards and Compendial Policy Department, responsible for developing and executing the operational strategy for three Program Units with direct responsibility over the development and execution of the scientific strategy for those areas, including documentary standards, new monograph development and revision, monograph modernization, and the USP-NF. In addition, the incumbent will closely work with their peer(s) in the marketing/business functional area and share accountability for the success of the overall PUT strategies. The incumbent leads a team of senior leaders, each with their own team of direct and matrixed reports. In addition, the Senior Director leads and develops his/her staff through mentoring and coaching to cultivate future science leaders. The Senior Director will also serve as a member of the department’s leadership team.
Roles and Responsibilities
Develops and executes a program strategy for the monograph development process to support the USP-NF, pending monographs and other monograph initiatives. Drives the implementation of a common process for monograph development to be implemented across Excipients, Foods, and Dietary Supplements and Herbal Medicines.
Responsible for the executing the strategy for three Program Units with direct responsibility for the scientific strategy and shared accountability for the success of three PUT strategies (excipients, foods, dietary supplements and herbal medicines.
Leads a department responsible for the development of new monographs, revisions of monographs, accelerated revisions, monograph redesign, query support and other tasks related to monograph development.
Develops the annual budget for revenue, expenses, and operating change targets for the area of responsibility and ensures adherence to budget. Identifies solutions to budget constraints to ensure goals and objectives are not hindered.
Establishes and maintains productive relations with the Council of Experts, Expert Committees, Project Teams, and Advisory Panels to ensure the highest quality monographs and reference standards.
Drives resolution of technical and/or compendial issues related to monographs in accordance with the Rules and Procedures of the Council of Experts, USP guidelines, standard operating procedures and other established USP practices.
Collaborates closely with all USP staff /departments for establishing new processes and/or process improvement initiatives in areas of interest.
Tracks and reports frequently on the status of all department activities.
Leads and develops staff within the department, encourages professional development by assisting in identifying opportunities for learning and professional growth.
Drives USP’s Science and Standards Voice, internally and externally, including the use of USP’s tools and solutions.
Supports and executes the USP strategies, including the Science Quality Framework.
BS in Chemistry, Biology, Pharmacy, pharmaceutical sciences, regulatory science or a related field twelve (12) years of regulatory or industry experience* An equivalent combination of experience and education may be substituted.
Seven (7) years demonstrated leadership and management of a diverse and multi-faceted staff in a matrix environment
Five (5) years of experience working in the area of compendial or regulatory science, such as the development, use, and applicability of quality standards.
Strong understanding of global regulatory frameworks, standard-setting organizations, regulatory agencies, trade and professional associations, and other public health organizations.
Ability to influence without direct authority, solid track record of solution-driven focus in a complex environment.
Strong understanding of USP policies and processes.
Demonstrated expertise in pharmaceutical analysis including separation science and other purity-indicating techniques
Management of a diverse and multi-faceted staff including Directors, scientists, and support staff
Demonstrated ability to communicate complex ideas clearly and concisely
Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills
Demonstrated ability to translate strategy into action
Strong influence, negotiation, teamwork and presentation skills
One (Senior) Office Administrator
Three Heads of Science PUTs.
USP offers an impressive benefits package , including:
Generous paid time off – 14 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.
Job Category Scientific