The U.S. Pharmacopeial Convention (USP) Scientist III, Materials Characterization in Rockville, Maryland
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 Polymer and Material Characterization. Polymers are either synthetic or sourced from natural products and have increasing applications in new drug formulations and dosage forms. Initial focus of the project will concentrate on the laboratory activities to evaluate technologies, to address the material characterization requirements (identification and composition) of polymers for potential inclusion in USP documentary and physical standards. The successful candidate will have experience in the use and application of technologies such as Size Exclusion Chromatography (SEC)/Gel Permeation Chromatography (GPC), Multi-Angle Light Scattering (MALS), Nuclear Magnetic Resonance (NMR) and Matrix-Assisted Laser Desorption/Ionization-Time of Flight (MALDI-TOF) technologies or other related technologies and skills. Knowledge of data analytics, and/or 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:
The structural characterization of polymer attributes such as molecular weight, polydispersity, monomer ratio/block size and end group functionalization. The initial work will focus on Poly(lactic-co-glycolic acid) (PLGA) but will also consider other polymers as appropriate such as Polyethylene Glycol (PEG).
Landscape, outline and recommend current and emerging technologies with respect to polymer characterization for further investigation for USP.
Collaborate with Translational Informatics department on database of polymers recognized by FDA to potentially prioritize for USP development and Extractables and Leachable Safety Information Exchange (ELSIE) Database to understand its impact on Polymer materials; Collaborate with the Excipients DOC Scientists on topics relating to proposed naming /architecture and the impact on polymer materials.
The successful candidate is expected to initiate and perform 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, informatics and digital innovation.
This is a two (2) year fixed-term position from the date of hire.
Roles and Responsibilities
Responsible for developing and performing appropriate laboratory research to successfully complete the project.
Provides process expertise including managing project tasks via interacting with the Excipients Department and the Analytical Development Laboratory as well as other internal and external stakeholder as appropriate in order to create an achievable work schedule.
Conducts research into processes and techniques of relevance to polymer identification and characterization.
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 analysis to identify problems or determine process controls necessary to mitigate risks to data quality.
Reviews, interprets, and evaluates available scientific literature, in order to provide and assist in the technical landscaping of polymers and advanced technologies and applications in polymer industry.
In collaboration with appropriate internal stakeholders, develops an understanding of and drives USP’s mission on development of public standards
PhD. +0 years in scientific discipline, with spectroscopy and polymer experience or related field, or
MS. +5 years in scientific discipline, with spectroscopy and polymer experience or related field.
Experience in performing research in the analysis and characterization of Polymers
Understanding of polymer architecture and characterization. Hands on experience in usage of HPSEC/RI, HPSEC/MALS/RI, NMR and other appropriate technologies.
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;
Familiarity and ability to execute good laboratory practices (GLP);
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
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 1st, 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