Science Program Manager-Continuous Manufacturing (792-679)
This is a non-supervisory professional position responsible for supporting the execution of the R&I strategic programs in Continuous Manufacturing and reporting to Program Dir, R&I. The incumbent in this role will be responsible for program management and coordinating activities that facilitate the Pharmaceutical Continuous Manufacturing Stakeholder engagement activities. The Science Program Manager is responsible for seeking and coordinating the collaborative efforts from laboratories, universities, pharmaceutical industries, and other organizations that have expertise and interested in standard setting of pharmaceutical continuous manufacturing. This individual will engage in proactive activities which are related to CM standard setting in terms of collaboration, new technology development, regulatory exploration, and compendial establishment. The Program Manager will represent USP at various external stakeholder engagement events and interactions.
Roles and Responsibilities:
- Create and manage scientific program content related to the standard setting of continuous manufacturing.
- Interface with cross-functional and global staff to ensure work integration and alignment with the global work plan
- Performs other duties as assigned
- Secure services as needed from other departmental, divisional, and organizational groups
- Manage the roadmap establishment for standard setting at CM
- Coordinate all activities for CM expert panel and related Expert Committee process
- Work with Program Unit Heads and project teams to develop processes and identify resources to support strategic engagement with CM stakeholders
- Create and manage external strategic stakeholder relationships relevant to key CM technology developments and emerging strategic markets of interest for USP
- Develops strong working relationships with internal and external stakeholders at all organizational levels
- Facilitates group interactions through interpersonal and tool-based skills to achieve project goals
- Help coordinate CM EP and attend Expert Committee meetings in relevance
- Establishes effective communication mechanisms with key stakeholders to inform on project information
- Manages issues and escalates appropriately
- Expertise and well established knowledge in continuous manufacturing practices and associated professional activities
- Basic skills in chemical engineering/ chemistry
- Understanding of basic USP standards-setting processes and compendial terminology
- Knowledge of global pharmaceutical manufacturing industries and related quality/regulatory requirements/processes/systems
- Expertise in evaluating research of evidence-based information
- Superior interpersonal skills: professionalism, accountability, helpfulness, delegation, and customer service
- Demonstrated ability to influence without direct authority at all organizational levels
- Demonstrated ability to understand and deliver on scientific and business objectives
- Able to effectively prioritize and efficiently manage multiple programs
- Advanced critical thinking and problem solving skills
- Excellent verbal and written communication skills
- Excellent presentation, interpersonal, and reporting skills
- Strong organizational skills and attention to detail
- Strong time management skills
- High accountability and drive for results
- Computer competence (MS Office programs, e-mail, and workflow systems)
Ph.D. with a minimum of 5 years, or M.S. with 8 years of relevant experience preferably in chemical/biochemical engineering; alternatively chemistry with pharmaceutical, biotechnology or life science industry experience may be applicable.
Experience managing or leading multiple, complex, cross-functional projects is essential. Experience working with external stakeholders is required. Experience in project planning and project management.
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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular