The U.S. Pharmacopeial Convention (USP) (Associate) Scientific Liaison, General Chapters- Chromatography in Rockville, Maryland
This is a professional scientific position in the General Chapters Group within the Compendial Science Department. The incumbent is responsible for providing support in the development and revision of quality policies incorporated in to the USP-NF general chapters mostly related to chromatography and validation and supports USP Expert Committees and associated Expert Panels. These activities will require stakeholder engagement, the critical evaluation of relevant documents and other information, the performance of literature searches on related topics and the development and drafting of pertinent documents for other scientific staff and/or Expert Committee review.
Roles and Responsibilities include
Works closely with a team of high-performing scientists responsible for the development and revision of documentary standards and the development of compendial quality policies.
Facilitates all aspects of the development and revision of USP-NF General Chapters, from development of the initial proposal to the publication of the documentary standard.
Evaluates and analyzes supporting data and translates into USP editorial style and format.
Assists in the activities of the USP Expert Committees and Advisory Panels, as needed.
Responds to telephone and written inquiries pertaining to USP-NF monographs and General Chapters included in the USP-NF.
Serves as a member on USP cross-functional teams, as needed
Keeps abreast of current trends and developments in related scientific fields.
Communicates with other USP departments regarding projects related to chromatography and analytical procedures validation
Associate Scientific Liaison:
PhD. in Chemistry, Biochemistry or allied field with a minimum of 5 years, or M.S. with a minimum of 7 years of relevant experience with USP-NF test and standards required.
Minimum of 5 years of experience with chromatographic techniques and validation of analytical procedures is required, acquired working in a quality control laboratory in the pharmaceutical industry.
Demonstrated knowledge of global regulatory environment and requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc), more specifically organic impurities (e.g.,ICH Q3 A/B).
PhD. in Chemistry, Biochemistry or allied field with a minimum of 8 years, or M.S. with a minimum of 10 years of relevant experience with USP-NF test and standards required.
Minimum of 8 years of experience with chromatographic techniques and validation of analytical procedures is required, acquired working in a quality control laboratory in the pharmaceutical industry.
Demonstrated knowledge of global regulatory environment requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.), more specifically organic impurities (e.g. ICH Q3 A/B)..
Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
Strong presentation and communication skills (written and oral).
Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills. Knowledge of internet and electronic database searches helpful.
Practical experience in scientific, analytical techniques.
Project Management skills required. Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
Ability to prioritize tasks and manage multiple projects simultaneously. 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.
USP offers an impressive benefits package, including:
Generous paid time off – 15 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.
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.
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