U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Senior Scientist I/II, Biologics in Rockville, Maryland

Description

Summary of the Position

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 Senior Scientist facilitates the development of USP 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 therapeutic proteins, peptides, 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 therapeutic proteins, peptides, and vaccines.

  • Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.

  • Plans and oversees necessary laboratory work for method development and verification, and reference standard evaluations.

  • Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.

  • 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.

  • 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.

  • Designs and oversees the execution of collaborative testing, once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.

Basic Qualifications

Sr. Scientist I

  • Ph.D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. Minimum of five (5) years of experience with bioanalytical development in the pharmaceutical industry.

  • MS. level candidates with minimum of seven (7) years of commensurate experience.

  • Combination of relevant work experience and education may be substituted

Sr. Scientist II

  • Ph.D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. Minimum of eight (8) years of experience with bioanalytical development in the pharmaceutical industry.

  • MS. level candidates with minimum of ten (10) years of commensurate experience.

  • Combination of relevant work experience and education may be substituted

Preferred Qualifications

  • Experience with pharmaceutical and biotechnology product development and characterization

  • Hands-on experience with bioanalytical technologies, such as HPLC, LC-MS, CE, ELISA, and qPCR

  • Preferable experience with analytical techniques of recombinant therapeutic proteins and/or vaccines

  • Ability to write technical reports related to material characterization, references standard evaluations, and method development.

  • 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.

  • 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.

Supervisory Responsibilities

None

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully present vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

About USP

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

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