Senior Scientist I/II/Principal Scientist, Documentary Standards

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hard-working professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, to the partnerships we build, to the conversations we foster, we affirm the crucial value of Diversity, Equity, Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare. Part of this commitment includes an emphasis on professional development of all staff and leadership training for managers. These include advancing core competencies such as Inclusive Management Style, Coaching/Mentorship and Adaptive Leadership to name a few.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

SENIOR SCIENTIST I/II/PRINCIPAL SCIENTIST, DOCUMENTARY STANDARDS

Brief Job Overview

This position is a non-supervisory hands-on, technical role that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP-NF monographs for drug substances and drug products working in close collaboration with USP’s Small Molecules Expert Committees and our volunteers.

How will YOU create impact here at USP?

• Oversees and facilitates all aspects of the development of documentary Standards for the USP-NF. Evaluates and analyzes supporting data and converts into USP editorial style and format.

• Collaborates with other USP departments on documentary standards-related issues.

• Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor.

• Assists in the activities of the USP Expert Committees and Expert Panels, as needed.

• Provides general scientific related support to other scientific and managerial staff.

• Responds to inquiries pertaining to USP-NF monographs and General Chapters.

• Writes general and specific subject correspondence pertaining to USP standards

• Stays ahead of current trends and developments in related scientific fields.

• Communicates with other USP departments regarding projects related to validation studies, method development, and reference standards.

• Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned).

• Performs other related duties as required.

Who is USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with collaborators, along with the following competencies and experience:

The candidate must have strong analytical chemistry knowledge with the ability to review, analyze, interpret and report effectively on data from a variety of analytical instrumental tests (e.g., GC, HPLC, NMR, ICP, AA, KF, UV, LC/MS, GC/MS). Well-developed organizational and interpersonal skills. A strong communicator (written and verbal) able to share information with scientific and non-technical staff and external partners from the pharmaceutical industry, government, and academic institutions. Able to establish and cultivate relationships with individuals of varying backgrounds, cultures and learning styles.

Senior Scientist I: BS with 9 years of minimum relevant experience; or MS with 7 years; or Ph.D. degree in Chemistry, Engineering, or a related scientific field with 5 years.

Senior Scientist II: BS with 12 years of minimum relevant experience; or MS with 10 years; or Ph.D. degree in Chemistry, Engineering, or a related scientific field with 8 years.

Principal Scientist: MS with 12 years of minimum relevant experience; or Ph.D. degree in Chemistry, Biochemistry, or a related scientific field with 10 years.

Additional Desired Preferences

• Broad pharmaceutical industry experience in CMC development of active pharmaceutical ingredients and drug products.

• Strong knowledge regarding the development, validation, and application of modern analytical techniques to the testing of pharmaceuticals.

• Knowledge of global regulatory requirements and guidance (e.g. FDA, ICH, etc.) relevant to pharmaceutical products.

• Able to lead and coordinate strong cross-functional teams. Able to prioritize tasks and manage multiple projects simultaneously.

• Able to distill large amounts of information into executable strategies and workplans

• Able to adapt landscapes, strategies, and workplans based on organizational/partner needs and constraints.

• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.

• Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.

• Able to establish and cultivate relationships with individuals of varying backgrounds, cultures and learning styles.

• Able to operate independently yet understands when to raise issues and how to establish effective working relationships.

• Strong presentation and communication skills (written and oral).

• Expertise in site-to-site transfer of methods and method equivalency.

• Experience authoring reports for the CMC section of the CTD used for IND or product applications for global submissions a plus.

• Experience with sophisticated manufacturing technology (AMT), process analytical technology (PAT) a plus.

• Experience with the development and/or commercialization of complex generics products a plus.

• Experience knowledge of organic chemistry especially with regards to formation of impurities a plus.

• Experienced knowledge on risk assessment and the establishment of control strategies for all classes of impurities in pharmaceutical drug substances and drug products a plus.

Supervisory Responsibilities

• None.

Benefits

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 is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must 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)