Senior Scientist I, Documentary Standards

Description

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

This is a hands-on, non-supervisory, non-laboratory role that serves as the liaison between the biopharmaceutical industry, regulatory agencies, USP departments and USP Expert Committees. The Documentary Standard Sr. Scientist facilitates the development of USP standards used by the global pharmaceutical industry. In this role, the incumbent will provide expertise, leadership, and guidance to USP Expert Committees and Expert Panels in the areas of mAbs, therapeutic proteins, peptides, oligonucleotides, antibiotics, gene therapy and vaccines, by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health.

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.

The SSI has the following responsibilities:

Roles and Responsibilities

• Works with key stakeholders to develop new and innovative standards for biotechnology pharmaceutical products including mAbs, therapeutic proteins, peptides, oligonucleotides, antibiotics, gene therapy and vaccines.
• Oversees and facilitates the development of standards and solutions to address analytical challenges associated with the next generation of biological medicines.
• Conducts scientific review to the supporting documents for the documentary standard development.
• Plans and oversees necessary laboratory work for method development, validation and verification.
• Prepares standard proposals and provides assistance, as needed, for the USP Expert Committees and Expert Panels to help with the documentary standard development for decision, provides requested background information and coordinates laboratory work.
• Performs technical review during documentary standard development
• Communicates and maintains working relationships with other USP departments regarding projects related to documentary standards and other cross-cutting activities.
• Responds to stakeholder inquiries pertaining to USP-NF documentary standards.
• Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters.
• Performs other duties as assigned.

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:

Sr. Scientist I

• Ph.D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. Minimum of seven years of post-educational work experience in bioanalytical development for biotherapeutics.
• M.Sc in Analytical Chemistry, Biochemistry, or Biological Sciences with minimum of 11-13 years of commensurate industrial experience,
• Experience with pharmaceutical and biotechnology product development and characterization
• Hands-on experience with bioanalytical technologies, such as HPLC, LC-MS, CD, SEC-MALS, CE, ELISA, ddPCR and qPCR
• Experience with method development, validation, verification, and specification setting

Additional Desired Preferences:

• Knowledge of compendial standards and USP-NF Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
• Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations.
• Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
• Project management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.

Supervisory Responsibilities

No

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.

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

Job Category Chemistry & Scientific Standards

Job Type Full-Time