The U.S. Pharmacopeial Convention (USP) Scientist IV/V, Biologics in Rockville, Maryland

Scientist IV/V, Biologics

Tracking Code

1269-679

Job Description

This is a highly technical, hands-on, and non-supervisory position in USP’s Biologics & Biotechnology Laboratory. In this role, the scientist is responsible for method development and evaluation, characterization of biologics, and collaborative testing of biologics reference standards in support of the function and activities at Global Biologics and USP. The scientist will have mastered common techniques within the laboratory setting and is able to contribute to provide input and solutions to the challenging projects. The scientist will execute 70% - 100% of their work at the bench level.

Roles and Responsibilities

  • Performs analysis of biopharmaceutical test samples using a variety of analytical methods such as HPLC, mass spectrometry (MS), capillary electrophoresis (CE), and gel electrophoresis

  • Develops and validates analytical methods used for the measurement of attributes of biologics, develops validation protocols and execute the validation plans

  • Performs peer-review of analytical data and reports

  • Generates final reports and prepares data for presentations

  • Uses existing databases to document progress of projects. Track and report the status of assignments to management at the regular basis

  • Works with cross-functional teams within the organization to solve both technical and process-related issues.

  • Demonstrates strong technical skill and expertise in specific laboratory methods and troubleshoots instrumentation within area of expertise

  • Seeks out innovative ways to apply knowledge or skills to improve protocols and results

  • Actively engages overall project and ensures own work is aligned with overarching goals

  • Shares technical expertise with other lab staff and serves as a mentor for them

  • Recommends and implements new approaches or processes to improve laboratory operations

  • Assists lab head in planning, implementing and evaluating laboratory procedures/systems

  • Attends scientific seminars and conference

  • Performs additional tasks as required for the position

Basic Qualifications

Scientist IV: Ph.D. in Biochemistry or related field with five (5) years of relevant laboratory experience, or an MS in biochemistry or related field with seven (7) years of experience

Scientist V: Ph.D. in Biochemistry or related field with eight (8) years of relevant laboratory experience, or an MS in biochemistry or related field with ten(10) years of experience

An equivalent combination of education and experience may be substituted.

Laboratory experience must include analytical methods such as HPLC, mass spectrometry (MS), capillary electrophoresis (CE), and gel electrophoresis in general. Candidate must be experienced in assay development and validation protocols and procedures following ICH, FDA, and USP

Preferred Qualifications

  • Strong experience in biotherapeutics characterization, intact protein analysis, peptide mapping, and post translational modification analyses. Desired expertise in HPLC, LC-MS, CE, UV/Vis spectroscopy

  • Great understanding in protein chemistry, mass spectrometry and separation sciences;

  • Working knowledge of common analytical methods and procedures, and expertise in calibrating and operating analytical instruments required

  • Good understanding of cell-based assays and enzymatic assays, as well as other general analytical chemistry and biological principles

  • Experience in validation protocols and procedures following ICH and USP

  • Working experience in the pharmaceutical and/or biotechnology industry strongly preferred

  • Plans and conducts research projects independently and has the ability to build technical expertise in others by serving as a mentor

  • Ability to learn new technologies and strong computer, scientific, and organizational skills

  • Ability to summarize and present data at various meetings

  • Must possess excellent written and verbal communications skills as well as interpersonal skills

  • Results driven with demonstrated successful outcomes

  • Individual must possess the ability to handle multiple priorities in fast-paced environment

Supervisory Responsibilities

None

USP offers an impressive benefits package , including:

  • Generous paid time off – 13 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 ($250/individual or $500/family)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods 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.

Job Location

Rockville, Maryland, United States

Position Type

Full-Time/Regular

Job Category Scientific