U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist III, Spectroscopy and Spectral Libraries (2-Year Fixed Term) in Rockville, Maryland

Description

The Product Quality and Analytical Methods(PQAM) Department of USP’s Digital and Innovation Division (D&I) is seeking a fixed-term research scientist in the field of Spectroscopy and spectral libraries. Spectral libraries being defined as the acquisition and coordination of spectral data and images into searchable and useable databases. Initial focus of the project will concentrate on IR, NIR and Raman, both handheld and benchtop instrumentation. The successful candidate will have experience in the use and application of spectroscopic technologies and spectral libraries. Knowledge in the creation and use of spectral libraries, data science, and experience in performing market research is desirable. The project has both laboratory and non-laboratory components and as such, the candidate is expected to perform laboratory experiments and work in collaboration with documentary, laboratory and informatic scientists. The project has the following three objectives:

  • Performing gap analysis of needs and identifying requirements for best practices in the development, standardization and use of spectral data and libraries. This will be in collaboration with USP’s Documentary Standards group for the potential preparation of USP guidance’s and best practices of spectral libraries and databases.

  • Design and perform laboratory experiments using appropriate spectral technologies such as IR, FTIR, Raman using handheld and/or benchtop instruments as appropriate. The focus will be obtaining appropriate data to evaluate selected spectroscopic instruments and technologies. The data will be used to assess the feasibility of developing algorithm(s) for cross-comparability in collaboration with the Informatics Innovation department.

  • Landscape analysis of emerging spectroscopic technologies and spectral library applications. This will be used for the identification and prioritization of appropriate technologies for compendial applications.

The successful candidate is expected to initiate and preform the necessary research, both laboratory and non-laboratory, in accordance with the three objectives described above, interact with internal and external experts, and to communicate results as appropriate.

PQAM supports USP’s mission by conducting early research and incubation of projects and initiatives focused on exploring emerging technologies and trends that may impact USP or its industry stakeholders. Through primary research and development, PQAM collaborates with both internal and external partners to propose and inform opportunities for adoption of new technologies into standards and processes at USP. Our areas of interest range from advanced therapies, new analytical technologies, to informatics and digital innovation.

This is a two (2) year fixed-term position from the date of hire.

Roles and Responsibilities

  • Collaborates with General Chapters Department in development of guidance’s and best practices of spectral libraries, standardization and applications;

  • Performs landscaping and gap analysis of spectroscopic technologies and emerging trends and applications;

  • Collaborates with Informatics Incubation and other relevant departments in assessing algorithm development/potential machine learning processes for comparability of data;

  • Assesses laboratory data for trends and determination of additional needs;

  • Works independently to plan, develops and conduct laboratory research relevant to the development and application of spectral libraries in standards development;

  • Provides project and technical expertise, including managing project tasks via interacting with internal and external clients, other departments and with USP stakeholders;

  • Prepares evaluation reports and presents data internally within USP and externally to customers and stakeholders as appropriate

  • Troubleshoots methods and instrumentation issues. This will involve data mining, trending and analysis to identify problems or determine process controls necessary to mitigate risks to data quality;

  • Presents laboratory work and/or data to internal and external stakeholders as appropriate;

  • Reviews, interprets and evaluates available scientific literature

Basic Qualifications

  • PhD. +0 years in Chemistry and Spectroscopy or related field, or

  • M.S. +5 years in Chemistry and Spectroscopy or related field

  • Experience in performing spectroscopic research using IR, NIR and/or Raman using benchtop and/or handheld instruments

Preferred Qualifications

  • Capability to plan and conduct research independently;

  • Strong ability to collaborate with various internal and external stakeholders to achieve intended outcomes;

  • Data science, analytical and multi-tasking abilities;

  • Skilled in anticipating, troubleshooting and solving technical problems;

  • Research experience in spectral library or database;

  • Familiarity with the cGMP and/or ISO requirements for testing laboratories;

  • Excellent Project Management skills ;

  • Excellent communication and presentation skills, both verbal and written;

  • Takes personal responsibility to ensure work is delivered on time and is of the highest quality;

  • Knowledge in the design, plan and build guidelines for standardizing spectral library/database is a plus;

  • Knowledge of potential applications of Spectral Libraries is a plus.

Supervisory Responsibilities: None

COVID-19 Provisions

The following COVID-19 provisions will apply to selected candidate(s) hired:

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

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

DirectEmployers