Senior Scientist II, Biologics

USP / United States Pharmacopeia • Full-time • Rockville, MD, US • $127,250 - $160,750 / year • 1w ago

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities 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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.

Brief Job Overview

The Senior Scientist II 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. Technical focus for this position is on functional testing of biologics, especially using a variety of cell-based and ligand-binding assays. 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?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

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 especially for monoclonal antibodies, other protein therapeutics, and cell and gene therapies. The successful candidate will interact with internal groups as well as external collaborative laboratories as appropriate.

Develops, qualifies, and implements functional and some physiochemical methods to support the biologics portfolio. Focus is on functional bioassays and ligand-binding assays. Develops workplan, analyzes data and prepares reports and slides for internal and external presentations. Participates in additional reference standard testing, such as stability studies and replacement lot testing.
Extensive experience in functional characterization of biotherapeutics, especially for antibodies and other protein therapeutics.
In depth understanding of analytical chemistry and biological principles.
Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
Collaborates with a cross-functional team, including colleagues in the US and India to design and implement studies, solve issues, analyze data, review results, define next steps, and support transfer of analytical methods.
Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
Strong communication (written and oral) presentation skills and ability to tailor and 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.
Capability to build technical expertise in others by serving as a mentor.
Ability to lead both internal and external projects.
Ability to learn new technologies and strong computer, scientific, and organizational skills.

Who is USP 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

M.S. in Biochemistry or related field and 15 years of relevant laboratory experience related to monoclonal antibodies and proteins.
Ph.D. in Biochemistry or related field with 10 years of relevant laboratory experience related to monoclonal antibodies and proteins.
Strong interpersonal, and written and verbal communication skills.
Ability to work independently and to handle multiple priorities in a fast-paced environment; strong scientific, computer and organizational skills.

Additional Desired Preferences

Technical hands-on expertise in development and application of functional bioassays and ligand-binding assays. Expertise in one or more of the following areas is required: cell-based assays, ligand-binding and kinetic assays (such as SPR), flow cytometry.
Experience in designing and executing method validation or qualification following ICH and USP guidelines
Experience in a regulated laboratory (e.g. ISO, GLP, or GMP)
Additional experience in using common analytical techniques (such as HPLC, CE, Spectroscopy, ELISA and other immunoassays) for characterization of biotherapeutics is preferred
Working experience in the pharmaceutical and/or biotechnology industry strongly preferred

Supervisory Responsibilities

None, this is an individual contributor role.

Benefits

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

Compensation

Base Salary Range: USD $127,250-160,750 annually.

Target Annual Bonus: Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

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