Director, Science & Standards - Biologics (948-679)
The Director, Science – Biologics is a key managerial role within the Biologics Program Unit of the Science Division. The incumbent leads a team of Science and Standards Liaisons, ensuring alignment with the overall program unit and organization goals. The Director supervises the performance, training and development of the staff and ensures team work and collaboration within the team as well as with other key USP staff. The Director works closely with USP stakeholders across the organization to exchange information, obtain resources, solicit input, and advance the work; and support the work of the Biologics Expert Committees. The incumbent oversees all aspects of reference standards development and associated documentary standards, in order to support USP’s position as a global leader in providing value-added biological standards.
Roles and Responsibilities:
- Provides scientific and professional leadership to scientists working in the areas of biological standards development in accordance with established SOPs, business practices and procedures. Advises direct reports on reference standards development and monograph development and revision strategies.
- Provides policy and leadership support to the USP Council of Experts and their Expert Committees
- Manages and tracks department day-to-day activities, workload, deliverables and output; provides updates to the department vice president. Works with other groups/departments, as needed, to identify and resolve issues
- Establishes goals and metrics for the team, ensuring alignment with the program unit goals and organizational goals, and evaluates performance against established goals
- Supports the program unit with the development of new and/or revises existing processes to facilitate efficient and innovative standards development processes.
- Actively recruits new staff to support business needs, and contributes to the development the next generation of scientific leaders. Develops and implements training plans for staff.
- Participates in USP-based teams or committees to support business practices and initiatives
- Participates in the development of manuscripts for publication by USP (e.g., Stimuli articles) or in peer-reviewed journals, as needed.
- Represents USP at scientific conferences/meetings, and other events sponsored by USP and/or pharmaceutical industry and regulatory agencies.
- Participates in the teaching and/or development of USP’s professional education course materials.
- Collaborates with USP staff, regulatory bodies, stakeholders, other pharmacopeias on standards setting initiatives to develop globally recognized standards
- Performs other duties as assigned
Ph.D. in biochemistry, biology, or other relevant discipline with a minimum of 10 years of relevant industry experience. Minimum of 3 years of experience working with large molecules, supervising, leading teams, training, or mentoring of other staff members, including scientific staff.
- Strong experience in the areas of characterization and analysis of biopharmaceuticals.
- Knowledge of compendial standards related to biopharmaceutical products/industry.
- Experience with the development and management of reference standards, is highly desirable.
- Strong understanding of the regulatory requirements and guidelines applicable to biopharmaceuticals.
- Demonstrated success in a people leadership role. Strong business acumen combined with both management and leadership ability.
- Effective coach and mentor to staff. Ability to identify and develop talent.
- Demonstrated stakeholder collaboration experience, with the ability to quickly develop and manage internal and external relationships and contacts.
- Excellent written and verbal communication skills, including ability to develop and deliver presentations to Senior Management and the entire organization.
- Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make quick strategic recommendations.
- Ability to lead in a fast paced environment with changing deadlines and priorities
- 5-7 Science and Standards Liaisons
USP offers an impressive benefits package, including:
- Generous paid time off – 13 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 Location Rockville, Maryland, United States Position Type Full-Time/Regular