(Senior) Science & Standards Liaison, Biologics (824-679)

Location
Rockville, Maryland, United States
Posted
Jan 11, 2017
Closes
Jun 01, 2017
Hours
Full Time

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 800 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.

This is a hands-on, non-supervisory role that serves as the liaison between the pharmaceutical/biotechnology industry, regulatory agencies, USP departments and USP Expert Committees. The Liaison facilitates the development of the USP documentary standards and reference standards used by the global pharmaceutical industry. In this role, the incumbent will provide expertise, leadership, and guidance to USP Expert Committees and Expert Panels by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health.

 

Roles and Responsibilities:

  • Oversees and facilitates all aspects of the development of monographs and General Chapters to the USP-NF, from receipt of the initial submission to the publication of the documentary standard. Evaluates and analyzes specifications and supporting validation data, and translates specifications and test methods into USP editorial style and format.
  • Writes general and specific subject correspondence pertaining to monographs, general chapters, reference materials, and various USP policy issues. Plans and oversees necessary laboratory work for method development and verification as needed.
  • Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.
  • Keeps abreast of current trends and developments in related scientific fields, particularly in the area of synthetic peptides, recombinant therapeutic proteins, such as monoclonal antibodies and cytokines and their analysis. Additional areas of interest are cell and tissue-based therapies.
  • Responds to stakeholder inquiries pertaining to USP-NF monographs, reference standards and General Chapters (as assigned). 
  • Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned).
  • Prepares standards proposals and provides assistance, as needed, for the USP Expert Committees and Expert Panels of the Council of Experts – e.g, coordinates chapter drafting activities, helps with the development of monograph proposals for decision, provides requested background information and coordinates necessary laboratory work, as needed.
  • Supports the development of USP reference materials for biologic monographs and test chapters.
  • Establishes reference standard configuration based on the uses of the standard in the monograph or chapter.
  • Designs and oversees the execution of collaborative testing, once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.
  • Develops reference standard candidate evaluation packages. Coordinates and submits candidate package to the approving expert committee.
Required Skills
  • Experience with pharmaceutical and biotechnology product development.
  • Specific areas of interest are carbohydrates, therapeutic peptides and proteins. Experience with cell, gene and tissue-based products is a plus.
  • Experience with reference materials development.
  • Ability to write technical reports related to material characterization, references standard evaluations, and method development.
  • Experience in method development and characterization of products and impurities using a variety of physicochemical techniques (e.g., HPLC, CE, MS, etc.)
  • Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
  • Knowledge of IND and BLA filings
  • 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.
  • Practical experience in scientific, analytical techniques.
  • Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
  • 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 persuade corporations to collaborate with USP on various projects.
  • Experience with, and knowledge of the USP-NF is preferred.
Required Experience

Science & Standards Liaison

Education

Ph.D. degree in Biochemistry, Virology, Biology, or Pharmacy, or a related field

Experience

Eight (8) years of relevant experience, or an M.S. and ten (10) years of relevant experience in analytical development for protein therapeutics. An equivalent combination of experience and education may be substituted. Experience with reference materials development is a plus.

Senior Science & Standards Liaison

Education

Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field

 

Experience

Ten (10) years of relevant experience, or an M.S. and twelve (12) years of relevant experience in analytical development for biotherapeutics that includes at least 5 years in a regulated biopharmaceutical environment. An equivalent combination of experience and education may be substituted. Experience with reference materials development is a plus.

Supervisory Requirements:

None

USP is proud to be an equal opportunity/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.

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