(Associate) Scientific Liaison-Chemical Medicines (939-679)

6 days left

Location
Rockville, Maryland, United States
Posted
Aug 09, 2017
Closes
Aug 26, 2017
Hours
Full Time

This is a non-supervisory scientific position in the Chemical Medicines Department (CM) reporting to Director/Team Leader. The role is that of an individual contributor. The incumbent is responsible for the development of monographs for small molecular-weight pharmaceuticals (drug substances and associated dosage forms) in the USP-NF and supports USP Expert Committees and associated Expert Panels. The department works closely with Reference Standards Evaluation (RSE) Compendial Development Laboratories (CDL) within Global Laboratory Organization (GLO) and other departments such as Publications (PUBS), Executive Secretariat and Compendial Affairs.

Roles and Responsibilities:

  • Develops new monographs and revises existing monographs based on supporting data submitted by USP global laboratories and external sponsors
  • Evaluates analytical methodology and acceptance criteria
  • Redesigns 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
  • Serves as a mentor for other staff and leads training efforts, as needed
  • Serves as a member on USP cross-functional teams, as needed
  • Prepares manuscripts for publication by USP (e.g. stimuli articles) or in peer-reviewed journals
  • Represents USP at scientific conferences/meetings, outreach visits and other events sponsored by USP, the pharmaceutical industry, trade organizations and regulatory agencies
  • Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor, as needed
  • Collaborates closely with Compendial Development Laboratories, Reference Standards Evaluation, Reference Standards Laboratories, Publications, Executive Secretariat, Compendial Affairs and other departments on monograph-related issues
  • Tracks and reports frequently to management on the status of assignments
  • Performs other duties as assigned

Basic Qualifications: 

Scientific Liaison:

  • Ph.D. in Chemistry, Biochemistry or allied field with a minimum of 8 years, or M.S. and 10 years of relevant experience with USP-NF tests and standards
  • Minimum of 8 years of experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titration, etc.
  • Knowledge of compendial standards related to pharmaceutical industry
  • Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.)
  • An equivalent combination of experience and education may be substituted

Associate Scientific Liaison:

  • Ph.D. in Chemistry, Biochemistry or allied field with a minimum of 5 years, or M.S. and 7 years or B.S. and 10 years of relevant experience with USP-NF tests and standards
  • Minimum of 5 years of experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titration, etc.
  • Knowledge of compendial standards related to pharmaceutical industry
  • Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.)
  • An equivalent combination of experience and education may be substituted

 

Preferred Qualifications: 

  • 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

 

Supervisory responsibilities:

None

  

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. 

Required Experience Job Location Rockville, Maryland, United States Position Type Full-Time/Regular