The U.S. Pharmacopeial Convention (USP) (Assistant/Associate) Scientific Liaison, Excipients in Rockville, Maryland
The (Assistant/Associate) Scientific liaison position is a professional, scientific position, non-supervisory and individual contributor role in which the incumbent is responsible for providing general scientific and operational support within the Global Science and Standards Division reporting to a management position (Sr. Manager or Director) in the Excipients Program Unit (EXC PUT). Key responsibilities include support for the development, update, and harmonization of Excipient monographs and general chapters in the USP-NF that are part of the USP-NF and Pharmacopeial Discussion Group (PDG, (EP, JP and USP)). The incumbent will utilize his or her technical expertise, knowledge of the compendial monograph standard development process and current regulatory guidelines, and strong organizational and communication skills to ensure timely development of high quality monographs and general chapters. The EXC PUT works closely with the Expert Committees, Global Science and Standards Division, Regional and Programs Operations, Volunteers Operations, as well as Publications, Legal, Strategy, and People, Global External affairs (GEA).
Roles and Responsibilities
Works with USP staff, relevant USP Expert Committee(s), subcommittees, and Expert panels, JP/EP Expert committees, and their regulatory bodies, stakeholders, and other pharmacopeias as related to Excipient monograph and general chapter international harmonization through the PDG process, or other bilateral or multilateral initiatives
Supports in the preparation of PDG briefing materials and correspondences to EP and JP colleagues; manages projects appropriately and ensures impeccable work-product delivery.
Participates in USP on site PDG meetings, scientific conferences/meetings, outreach visits and other events sponsored by USP and/or pharmaceutical industry and regulatory agencies and provides scientific expertise at PDG meetings, internal and external meetings, scientific symposia, industry forums, and Expert Committee meetings.
Standard setting responsibilities include:
Prepares PDG briefing materials and other technical documents for correspondence with EP and JP colleagues.
Manages action items from monthly EC PDG subcommittee telecom meetings.
Tracks and reports frequently on the status of assignments to management;
Facilitates the accomplishment of key departmental metrics.
Assists in writing manuscripts for publication by USP (e.g., PF harmonization proposals, stimuli articles) or in peer-reviewed journals;
Performs other related duties in support of the Excipients Program Unit as assigned.
Assistant Scientific Liaison:
- Ph.D. in Chemistry or Biochemistry and 2 years or MS in Chemistry or Biochemistry and 5 years, respectively, or relevant experience. An equivalent combination of experience and education may be substituted. Proficient in related analytical analysis and instrumentation (e.g., GC, HPLC, LC/MS, GC/MS, NMR, ICP, AA); demonstrate a fundamental understanding of analytical method development as well as method validation.
Associate Scientific Liaison:
- Ph.D. in Chemistry or Biochemistry and 5 years or MS in Chemistry or Biochemistry and 7 years, respectively, of relevant experience. An equivalent combination of experience and education may be substituted. Proficient in related analytical analysis and instrumentation (e.g., GC, HPLC, LC/MS, GC/MS, NMR, ICP, AA); demonstrate a fundamental understanding of analytical method development as well as method validation.
Experience and knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
Ability to review, analyze, interpret and report effectively on data from various analytical tests.
Understanding of excipient biopolymer chemistry and molecular structures with experience in usage of HPSEC/RI, HPSEC/MALLS/RI
Proficient with pharmaceutical testing requirements and test protocols involving compendial methods development for Excipient monographs within PDG (USP, JP, EP, etc.).
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. Ability to rapidly assess technical complications to identify, define, and solve technical issues
Routinely applies personal experience, academic training, and technical insights to solve technical problems
Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening and presentation skills.
Project Management skills and ability to prioritize tasks and manage multiple projects simultaneously.
Results driven with demonstrated successful outcomes.
Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
The ability to influence without direct authority.
Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
Ability to handle multiple priorities in a fast-paced environment.
Able to work flexible hours when needed.
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