The U.S. Pharmacopeial Convention (USP) (Senior) Principal Scientist, Continuous Manufacturing in Rockville, Maryland
Summary of the Position
This is a science leadership position that sets and executes the strategy for USP’s role in promoting the adoption of continuous manufacturing (CM) in the pharmaceutical industry, which USP believes will improve the quality and accessibility of medicines globally over time.
You will report to the Senior Director, General Chapters of the Documentary Standards and Compendial Policy division. As the lead for short and long-term strategy around CM adoption, your success will be defined by the level of impact the solutions you create. Your ability to collaborate, connect and communicate expertise internally and across the industry will contribute to this success plan. You will also apply an understanding of USP’s domestic and global role, pharmaceutical industry trends, stakeholder engagement, and customer dependency and usage of documentary standards while creating value for USP and for USP’s customers. In addition to overall strategy, you will direct a wide range of projects and tasks related to identifying and implementing solutions, including the development of technical guides.
This position will give you the opportunity to grow professionally, network with highly-experienced scientific leaders, use your creativity, independence, people skills, and technical knowledge to contribute to improving global public health and delivery of quality medicines.
Roles and Responsibilities
• Describe, build, and advance a vision and roadmap for CM standards and solutions.
• Lead cross-functional groups to focus efforts on specific knowledge domains and high-impact topics.
• Determine deliverables, requirements, and timelines for the development of CM standards and solutions.
• Responsible as primary author of a number of CM standards and solutions to be published by the USP.
• Assure consistent high quality of CM standards and solutions and guard that they are inclusive for all potential users of CM.
• Execute against the standards and solutions roadmap through tight integration of activities within USP and with external stakeholders, including but not limited to industry, academia, and regulators.
• Advocate for CM adoption in pharmaceutical industry and use of USP CM standards and solutions across the broader scientific and regulatory communities.
• Maintain awareness of the current trends and issues in the industry by attending scientific seminars, conferences, industry consortia meetings, and other fora.
• Represent USP science and standards at industry conferences and symposia as well as through written articles.
• Work closely with other USP departments to ensure CM-related standards and solutions are known, valued, and used through various service offerings such as education and training, consulting, and lab services.
• Lead internal and external CM capability-building activities, including training, education, and knowledge-sharing across the organization.
Ph.D. in chemistry, chemical engineering, or related field with at least 10 years of relevant experience; M.S. in chemistry, chemical engineering, or related field with at least 13 years of relevant experience. An equivalent combination of education and experience may substitute.
• 5 yrs of direct, practical experience in applying CM in the pharmaceutical industry and In-depth knowledge of several CM knowledge domains.
Senior Principal Scientist:
Ph.D. in chemistry, chemical engineering, or related field with at least 13 years of relevant experience; M.S. in chemistry, chemical engineering, or related field with at least 15 years of relevant experience. An equivalent combination of education and experience may substitute.
• 7 yrs of direct, practical experience in applying CM in the pharmaceutical industry and In-depth knowledge of several CM knowledge domains.
• Experience with commercial implementation of a control strategy in a CM line, and/or laboratory research environment
• Experience in development and implementation of PAT, including NIR and Raman spectroscopy, other at-/in- analytical instrumentation, and associated software.
• Knowledge of chemometric models and statistical principles and their applications to CM.
• Working knowledge of CMC regulatory requirements for API and/or Finished Dosage Form development.
• Excellent written communication skills required with a focus on scientific writing for the pharmaceutical industry.
• Excellent verbal communications skills required including the ability to speak with authority and respect.
• Good interpersonal skills required including the ability to form strong relationships with team members and industry stakeholders.
• Strong project management skills with ability to be effective both independently and in collaborative teams.
• Self-motivated and entrepreneurial.
• Known and respected within the pharmaceutical continuous manufacturing community.
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 are protected.
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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time