Principal Investigator- Pharmaceutical Continuous Manufacturing (1017-679)
This position is responsible for leading the execution of the Research and Innovation (R&I) strategic programs in Pharmaceutical Continuous Manufacturing (PCM) and reporting directly to the Vice President of R&I. The incumbent in this role will be responsible for strategic and operational leadership and influence over all aspects of USP’s PCM activities. With the growing interest in PCM from regulators and manufacturers, USP is bolstering its activities aimed at supporting the advance of PCM and driving improved quality by design through the development of standards, and potentially other related activities. The Principal Investigator is responsible for establishing an in-house program as well as seeking and coordinating collaborative efforts from laboratories, universities, pharmaceutical industries, and other organizations that have expertise and interests in pharmaceutical continuous manufacturing. This individual will directly engage in or influence activities including standard setting, technology development, regulatory exploration, training, education and consultancy and so forth. The Principal Investigator will also represent USP at various external stakeholder engagement events and interactions.
Roles and Responsibilities:
- Develop and lead the overall USP strategy for PCM
- Work cross-functionally to champion and implement the PCM strategy
- Collaborate with the Compendial Science Group to create and manage the standard setting program for PCM, in particular working closely with the General Chapters department and associated Expert Committees and Expert Panels as required
- Interface with cross-functional and global staff to ensure work integration and alignment with the global work plan
- Secure services as needed from other departmental, divisional, and organizational groups, including but not limited to Strategy & Business Development
- Work with Program Unit leads and project teams to develop processes and identify resources to support strategic engagement with PCM stakeholders
- Create and manage external strategic stakeholder relationships relevant to key PCM technology and regulatory developments and emerging strategic markets of interest for USP
- Develop strong working relationships with internal and relevant external stakeholders at all organizational levels
- Facilitate group interactions through interpersonal and tool-based skills to achieve project goals
- Manage issues and escalate appropriately
- Performs other duties as assigned
- Ph.D. with a minimum of 5 years, or MEng or M.S with a minimum of 8 years of relevant experience preferably in chemical/biochemical engineering; alternatively chemistry with pharmaceutical, biotechnology or life science industry experience may be applicable.
- Exposure to working in a manufacturing or production environment.
- Experience managing or leading multiple, complex, cross-functional projects is essential.
- Experience working in a matrixed environment, with a demonstrated ability to influence subject matter experts to successfully deliver technical projects is essential.
- Experience working with external stakeholders is required.
- Experience in project planning and project management.
- Experience in industrial manufacturing preferred, with a keen interest in continuous manufacturing or related technologies and approaches.
- 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
- 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 technical and executive verbal and written communication skills
- Excellent technical and executive presentation, interpersonal, and reporting skill
- 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)
May supervise one or more individuals as the program develops. Indirect, functional stewardship (matrixed) responsibility over individuals involved in PCM activities (standard setting, education, training, consultancy, etc. as appropriate)
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