The U.S. Pharmacopeial Convention (USP) Senior Scientist I/ Senior Scientist II, Global 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 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 methods such as cell-based bioassays, ligand binding assays, enzymatic assays, immunoassays, anti-microbial potency testing, protein and nucleic acid analysis
Develops and evaluates validated methods used for the measurement of biological attributes, develops validation protocols and execute the validation plans
Performs peer-review of data along with collaborative test and research reports
Generates final reports and prepares data for presentations to internal and external stakeholders
Uses existing databases to document progress of projects. Track, report and communicate 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, interest 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 fellow lab staff and serves as a mentor for them
Recommends and implements new approaches or processes to improve laboratory operations, keeping up to date of current technological trends in the pharmaceutical industry
Assists lab head in planning, implementing and evaluating laboratory procedures/systems
Attends scientific seminars and conferences
Performs additional tasks as required for the position
Sr. Scientist I: 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 or a BS in biochemistry or related field with ten (10) years of experience
Sr. Scientist II: 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 or a BS in biochemistry or related field with fifteen (15) years of experience
An equivalent combination of education and experience may be substituted. Laboratory experience must include bioassay, potency tests, enzymatic assays, immunoassays, microbial testing, protein and DNA analysis in general. Candidate must be experienced in assay development and validation protocols and procedures following ICH, FDA, and USP
Thorough understanding and experience in functional assays for biologics, such as ELISA, potency tests, enzyme-based assays, ligand binding assays, microbial testing, nucleic acid analysis, and protein analysis
Experience in cell culture techniques and cell-based bioassay. Knowledge in cell immunofluorescence methods including fluorescent microscopic based method and flow-cytometric method is a plus.
Able to analyze and interpret data using appropriate statistical methods and calculations for relative potency determination, including but not limited to, PLA methods
Solid knowledge and experience using the statistical analysis software, for example, JMP, PLA & CombiStats
Good understanding and working knowledge of biotherapeutics characterization, intact protein analysis, peptide mapping, and post translational modification analyses.
Experience in validation protocols and procedures following ICH and USP-NF
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 meetings to a wide range of audiences
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
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