(Senior) Pharmacopeial Specialist (1062-679)

Location
Rockville, Maryland, United States
Posted
Mar 08, 2018
Closes
Jun 05, 2018
Hours
Full Time

This is a non-supervisory scientific position in the Chemical Medicines Department (CM) reporting to Director. The role is that of an individual contributor. The incumbent is responsible for providing support to Scientific Liaisons in the development of monographs for small molecular-weight pharmaceuticals (drug substances and associated dosage forms) in the USP-NF. In addition, the incumbent is responsible for workflow prioritization and management for a team of Scientific Liaisons, and providing regular reports on team progress to Directors and other parties as needed.

Roles and Responsibilities:

  • Workflow tracking and management, including regular communication with cross-functional teams, other departments (PUBS, CDL, SCD, PPM, etc.), Program Analyst and Chemical Medicines Scientific Liaisons
  • Update management and staff members on workflow management and prioritization
  • Supports leadership staff with information for strategy implementation and departmental goals
  • Leverages knowledge of analytical chemistry to redesign existing official monographs
  • Works closely with a team of high-performing scientists responsible for the development and revision of documentary standards
  • Works with USP staff, regulatory agencies, stakeholders, and other pharmacopeias as related to monograph development
  • Provides information to the relevant USP Expert Committee(s) in support of monograph development
  • Supports the preparation of manuscripts for publication by USP (e.g. stimuli articles) or in peer-reviewed journals
  • Collaborates closely with Compendial Development Laboratories, Reference Standards Evaluation, Reference Standards Laboratories, Publications, Executive Secretariat, Compendial Affairs and other departments on monograph-related issues
  • Meet with other Pharmacopeial Specialist to track progress toward goals, and anticipate potential bottlenecks; escalate problems to the leadership staff as needed
  • Performs other duties as assigned

Basic Qualifications

Pharmacopeial Specialist

  • B.S. in Chemistry or a relevant scientific discipline and 3 years of relevant experience with USP-NF tests and standards; or M.S.
  • Experience using analytical techniques such as chromatography, wet chemistry, spectroscopy, titration in a laboratory setting
  • An equivalent combination of experience and education may be substituted

Senior Pharmacopeial Specialist

  • B.S. in Chemistry or a relevant scientific discipline and 5 years of relevant experience with USP-NF tests and standards; or M.S. and 3 years of experience.
  • Experience using analytical techniques such as chromatography, wet chemistry, spectroscopy, titration in a laboratory setting
  • An equivalent combination of experience and education may be substituted

Preferred Qualifications

  • Knowledge of productivity software such as MS Office
  • Able to establish and nurture relationships with individuals of varying backgrounds and learning styles
  • Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills
  • Knowledge of internet and electronic database searches helpful
  • Knowledge of ChemDraw is a plus
  • Practical experience in scientific, basic chemistry and analytical techniques is a plus
  • Project Management skills required

 

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

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