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