The U.S. Pharmacopeial Convention (USP) (Associate) Scientist, Biologics in Rockville, Maryland
This is a hands-on, non-supervisory role that serves as the liaison between the biopharmaceutical 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 in the areas of advanced therapies, genomics and vaccines, by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health.
Roles and Responsibilities
Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including gene and cell therapies, genomics and vaccines.
Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.
Develops relationships and partnerships with key stakeholders, within the research, manufacturing and regulatory communities.
Writes general and specific subject correspondence pertaining to documentary standards, reference materials, and various USP policy issues. Evaluates and analyzes scientific reports and supporting validation data, and translates specifications and test methods into USP documentary standards.
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 areas of gene and cell therapies, genomics and vaccines.
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.
Designs and oversees the execution of collaborative testing, once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.
Associate Science and Standard Liaison
Ph.D. degree in Biochemistry, Biology, Immunology, or a relevant field. Minimum of five (5) years of post-educational work experience in bioanalytical development for biotherapeutics.
MS. level candidates with minimum of seven (7) years of commensurate experience.
BS. level candidates with minimum of ten (10) years of commensurate experience.
Science and Standard Liaison
Ph.D. degree in Biochemistry, Biology, Immunology, or a relevant field. Minimum of eight (8) years of post-educational work experience in bioanalytical development for biotherapeutics.
MS. level candidates with minimum of ten (10) years of commensurate experience.
BS. level candidates with minimum of fifteen (15) yrs of commensurate experience.
Experience with pharmaceutical and biotechnology product development and characterization for gene and cell therapies, genomics and vaccines.
Hands-on experience in performing immunoassays, qPCR, flow cytometry, and cell culture.
Preferable experience with analytical techniques of recombinant therapeutic proteins, peptides, and carbohydrates, such as HPLC, CE, cIEF, MS, and NMR
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 and biological assays.
Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
Knowledge of national and international regulatory filings approaches. 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).
Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
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.
USP offers an impressive benefits package, including:
Generous paid time off – 15 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.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time