U.S. Pharmacopeial Convention Jobs

Job Information

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

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 should have mastered common analytical techniques within the laboratory settings and be able to provide inputs 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 quality attributes of biologics, develops validation protocols and execute the validation plans

  • Performs peer-reviews of analytical data and reports

  • Writes final reports and prepares slides for presentations

  • Uses existing databases to document project progresses, tracks and reports the status of assignments to management on a 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 to be 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 conferences and makes presentations

  • Performs additional tasks as required for the position

Basic Qualifications

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

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

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. The candidate must be experienced in assay development and validation following protocols and procedures per ICH, FDA, and USP guidelines.

Preferred Qualifications

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

  • In-depth understanding of protein chemistry, mass spectrometry and various separation sciences;

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

  • Good understanding of general analytical chemistry and biological principles; understanding of cell-based assays and enzymatic assays is a plus but not required

  • Experience in preparation of validation protocols and procedures following ICH and USP guidelines

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

  • Experience in planning and conducting research projects independently, as well as mentoring others to build technical expertise

  • 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 – 15 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.

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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