U.S. Pharmacopeial Convention Jobs

Job Information

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

Description

Summary of the Position

The position is a one year fixed-term position that is focused on evaluation and performance of bioanalytical assays, with a focus on ligand-binding assays, potency assay and protein characterization to support USP’s efforts on biomarkers. The fellow will have a key role in evaluation, qualification and development of reference standards and critical reagents to support greater consistency of results across assays and analytical platforms. The position has both non-laboratory (method research, data analysis and data reporting) and laboratory functions (sample preparation and analysis using various assays). The successful candidate will collaborate with internal stakeholders as well as external collaborative laboratories as appropriate. In addition, the successful candidate will be expected to present results of their work internally as well externally, as appropriate.

Roles and Responsibilities

• Evaluate multiple sources of protein biomarkers and critical reagents for use as standards in immunoassays (ELISA and/or other immunoassay platforms) and other bioanalytical assays.

• Develop, qualify and/or validate bioanalytical assays to evaluate the impact of the reference standards on quantitation of the biomarkers in clinical samples. Compare data generated from various assay platforms.

• Develop methods with various separation technologies for analysis of purity, impurities, and specific variants of protein biomarker standards.

• Troubleshoot and resolve bioanalytical method issues.

• Prepare scientific reports and papers as needed or required. May include public presentation of data in appropriate venue(s).

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

Basic Qualifications

Scientist III:

• Ph.D. in biochemistry or related field with relevant laboratory experience, or an M.S. in biochemistry or related field with five (5) years of experience

Scientist IV:

• Ph.D. in biochemistry with two (2) years of experience; or related field with relevant laboratory experience, or an M.S. in biochemistry or related field with six (6) years of experience

Skills Sought

• Proficient in developing, troubleshooting, and validating (according to regulatory requirements) ELISAs and other immunoassays and ligand-binding assays.

• Experience with other analytical methods which may be relevant to protein biomarkers (e.g., HPLC, enzymatic assays, flow cytometry etc.)

• Experience in handling and analyzing biological molecules within various clinical samples (urine, plasma or serum).

Preferred Qualifications

• Ability to follow SOPs and established laboratory safety and regulatory policies.

• Independent, Self-starter requiring minimal oversight including the ability to design and perform experiments in fulfillment of the Fellowship.

• Track record of publications in peer-reviewed journals.

• Excellent analytical skills, ability to interpret complex data and design future experiments.

• Excellent communication skills, both spoken and written. Ability to impart knowledge to various groups with a range of experience.

• Prior experience in pharmaceutical, biotechnology or CRO industries. Experience working in a GLP/GCP environment is highly preferred.

• Knowledge of biomarker development. Experience with other ligand binding assay platforms such as Gyrolab, Singulex or MSD-based immunoassays is highly desirable.

• Experience with immunogenicity or auto-antibody assays.

• Experience with various analytical technologies, including HPLC, CE, SDS-PAGE or MS is highly desirable.

• Ability to interact with senior staff, both scientific and non-scientific.

• Results driven with demonstrated successful outcomes.

• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.

• Ability to handle multiple priorities in a fast-paced environment.

• Excellent written and verbal communications skills.

Supervisory Responsibilities

None

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

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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