Job Information
The U.S. Pharmacopeial Convention (USP) Senior Scientist I, Biologics Laboratory in Rockville, Maryland
Description
Who is 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Senior Scientist I role is a non-supervisory position that is responsible for development, evaluation, qualification and validation of methods and testing of reference materials to support development and maintenance of USP standards and tools. This laboratory-based position has both non-laboratory (method research, data analysis and data reporting) and laboratory functions (sample preparation and analysis).
How will YOU create impact here at USP?
Standards and tools that support quality and consistency of analytical methods for both existing and new therapeutic modalities are critical for improving the efficiency of biologics development. This position will support development and maintenance of physical and documentary standards by performing testing, method development, and method qualification/ validation to support standards for cell and gene therapies, monoclonal antibodies, vaccines, peptides, and other biotherapeutics. The successful candidate will interact with internal groups and some external collaborative laboratories as appropriate.
• Develops, implements, and qualifies analytical methods to support the biologics portfolio. Develops workplans, analyzes data and prepares reports and presentations.
o Experience in basic molecular and cell biology methods that can be used for characterizing biotherapeutics.
o Good understanding of analytical chemistry and biological principles.
o Able to follow written workplans and instructions, and also operate independently where appropriate.
• Collaborates with a cross-functional team, including colleagues in the US and India to design and implement studies, solve technical issues, analyze data, and discuss and define next steps within the team.
o Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
o Strong communication (written and oral) presentation skills and ability to clearly deliver content and presentations to internal and external stakeholders.
• Supports laboratory operations and global biologics program by following laboratory processes, sharing knowledge with colleagues, supporting adoption of new approaches and process improvements. Maintains and troubleshoots instrumentation.
o Utilize and adapt prior technical knowledge for biotherapeutics testing and development.
o Ability to lead projects.
o Ability to learn new technologies and strong computer, scientific, and organizational skills.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Ph.D. in Biochemistry or related field with 5 years of relevant laboratory experience, or
• M.S. in Biochemistry or related field and 10 years of relevant laboratory experience
• Strong interpersonal, and written and verbal communication skills.
• Ability to both follow written and verbal instructions, as well as work independently in a fast-paced environment; strong scientific, computer and organizational skills.
Additional Desired Preferences
• Technical hands-on knowledge of basic molecular and cell biology techniques, such as PCR (qPCR/dPCR), DNA/RNA isolation and characterization (UV/Vis spectroscopy, gel electrophoresis, other analytical methods), and basic mammalian cell culture techniques strongly preferred.
• Additional skills in cell-based assays, potency/binding assays, and protein characterization are preferred.
• Working experience in the pharmaceutical, biotechnology or life sciences industry is preferred.
• Working experience under regulatory or internal quality managements system is preferred.
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 is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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