U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Scientist IV- Postdoctoral Fellow in Rockville, Maryland

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Overview

This laboratory-based role is a non-supervisory position that is focused on development and implementation of mass spectrometry-based methods for characterization of bio-therapeutics. The fellow will primarily support a multi-laboratory project comparing the multi-attribute method (MAM) to conventional characterization methods. The fellow will also be responsible for method development and evaluation, characterization of biologics, and testing to support development and maintenance of USP reference standards. The position has both non-laboratory (method research, data analysis and data reporting) and laboratory functions (sample preparation and analysis).

How will YOU build impact here at USP?

Standards and tools that support quality and consistency of analytical methods for both existing and new therapeutic modalities are critical for improving the efficiency of biologics development. This position will support development and adoption of innovative methods for characterization of bio-therapeutics, with a focus on the mass spectrometry-based Multi-Attribute Method (MAM). The results of this work will help support transitioning from conventional techniques to MAM by creating a knowledge base that can lower the barrier to adoption of MAM and enable wider use of MAM by bio-therapeutic manufacturers. The successful candidate will interact with internal groups during the Fellowship as well as external collaborative laboratories as appropriate.

· [60%] Develops, qualifies, and implements methods for characterization of bio-therapeutics, with particular emphasis on mass spectrometry-based methods. Analyzes data and prepares reports and slides for internal and external presentations.

· [30%] Collaborates with a cross-functional team in the US and India to design and implement studies, solve issues, analyze data, review results, define next steps, and support transfer of analytical methods.

· [10%] Supports laboratory operations and global biologics program by following laboratory processes, sharing knowledge with colleagues, supporting adoption of new approaches and process improvements. Maintains and troubleshoots instrumentation.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with collaborators, along with the following competencies and experience:

· Ph. D. in biochemistry or related field

· Laboratory experience must include analytical methods such as HPLC and mass spectrometry (MS), with hands-on experience in peptide mapping, and post translational modification analyses of biologics

· Excellent interpersonal skills and written and verbal communication skills

· Ability to work independently and to balance multiple priorities in a fast-paced environment; Strong scientific, computer and organizational skills

Additional Desired Preferences

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor dis-qualifiers for candidate consideration.

· Working knowledge of common analytical methods and procedures, including CE, icIEF, HPLC, and forced degradation studies

· Good understanding of general analytical chemistry and biological principles

· Familiarity with ICH and USP guidelines

· Familiarity with Thermo Orbitrap Mass Spectrometers and related software including Biopharma Finder, Proteome Discover etc.

· Experience with analysis of bio-therapeutics

· Strong presentation skills and ability to tailor and deliver content and presentations to internal and external stakeholders

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 is 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 vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note: 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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