(Associate) Scientific Liaison, Excipients (895-679)

6 days left

Location
Rockville, Maryland, United States
Posted
Jun 05, 2017
Closes
Aug 26, 2017
Hours
Full Time

The 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 Science Division reporting to a management position (Director or Vice President) in the Excipients Program Unit (EXC PUT). Key responsibilities include support for the harmonization of Excipient monographs and general chapters in the USP-NF that are part of the Pharmacopeial Discussion Group (PDG, (EP, JP and USP)) or other bilateral or multilateral harmonization initiatives that will contribute to USP’s success within PDG, and USP’s harmonization strategy. The incumbent will utilize his or her technical expertise, knowledge of the PDG harmonization of compendial monograph standard development process and current regulatory guidelines, and strong organizational and communication skills to ensure timely development of high quality harmonized monographs and general chapters. The EXC PUT works closely with the Compendial Science Division for Collaborative Harmonization and Science-Operations as well as Publications, Global Laboratory Operations (GLO) and 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 though 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.

BASIC QUALIFICATIONS

  • Associate Scientific Liaison: Ph.D. in Chemistry, Biochemistry, or Pharmaceutical Science and 5 years or MS in Chemistry, Biochemistry, or Pharmaceutical Science and 7 years, respectively, of relevant experience. An equivalent combination of experience and education may be substituted.
  • Scientific Liaison: Ph.D. in Chemistry, Biochemistry, or Pharmaceutical Science and 8 years or MS in Chemistry, Biochemistry, or Pharmaceutical Science and 10 years, respectively, of relevant experience. An equivalent combination of experience and education may be substituted.
  • Experience and knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
  • Proficient in related analytical analysis and instrumentation (e.g., GC, HPLC, NMR, ICP, AA, KF, UV, LC/MS, GC/MS).

PREFERRED QUALIFICATIONS

  • Ability to review, analyze, interpret and report effectively on data from various analytical tests.
  • 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
  • Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening and presentation skills.
  • Proficient with pharmaceutical testing requirements and test protocols involving compendial methods development for Excipient monographs within PDG (USP, JP, EP, etc.).
  • The ability to influence without direct authority.
  • Results driven with demonstrated successful outcomes.
  • Project Management skills and ability to prioritize tasks and manage multiple projects simultaneously.
  • Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
  • 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 – 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