(Associate/Senior) Science & Standards Liaison ((Associate/Senior) Science & Standards Liaison)
This is a hands-on, non-supervisory scientific position that serves as the liaison between the pharmaceutical industry, regulatory agencies, USP departments and USP Expert Committee for antibiotics. The incumbent is responsible for the development and revision 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 documentary and physical references standards to be included in 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 documentary standards, reference materials, and various USP policy issues. Plans and oversees necessary laboratory work for method development and verification, and reference standard evaluations 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 antibiotics and bioassays.
- Responds to stakeholder inquiries pertaining to USP-NF documentary and reference standards
- Serves as representative of USP at professional scientific meetings organized by USP and other organizations. 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., helps with the development of monograph proposals for decision, provides requested background information and coordinates laboratory work, as needed.
- Supports the development of USP reference materials for antibiotics documentary standards.
- 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.
Associate Science and Standards Liaison:
- Ph.D. degree in Biochemistry, Chemistry, or Microbiology, or a related field and five (5) years of relevant experience, or an M.S. and seven (7) years of relevant experience in analytical development for biopharmaceuticals that includes analytical techniques such as chromatography, spectroscopy, and bioassays.
Science and Standards Liaison:
- Ph.D. degree in Biochemistry, Chemistry, or Microbiology, or a related field and eight (8) years of relevant experience, or an M.S. and ten (10) years of relevant experience in analytical development for biopharmaceuticals that includes analytical techniques such as chromatography, spectroscopy and bioassays.
Senior Science and Standards Liaison:
- Ph.D degree in Biochemistry, Chemistry, or Microbiology, or a related field and ten (10) years of relevant experience, or an M.S. and twelve (12) years of relevant experience in analytical development for biopharmaceuticals that includes analytical techniques such as chromatography, spectroscopy and bioassays. In addition, at least 5 years of this experience should be in a regulated pharmaceutical environment.
- Experience with reference materials development.
- Experience with microbiological assays for measurement of antibiotic potency
- Experience with pharmaceutical product development (drug substances and associated dosage forms)
- Experience with validation criteria for replacement of microbial assays by HPLC methods is desired
- Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations.
- 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). Ability to write technical reports.
- Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
- 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.
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