Scientist IV Senior Scientist I, Documentary Standards

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a hands-on non-supervisory non-laboratory role in the India Biologics department. The incumbent will support the reference standard development program within the Global Biologics department. The incumbent will participate in the development of replacement and new reference standards /ARMs in support of USPs Mission and core business. The incumbent in this role will also focus on supporting the Constinued Suitability for Use (CSU)/Retest program including preparing CSU testing protocols and CSU/Retest reports will also provide technical assistance to testing labs review analytical data and prepare summary reports to assist in the continued suitability of USP Reference Standards (RS).

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Scientist-IV/SSI has the following responsibilities:

• Works with key stakeholders to develop reference standards for biotechnology pharmaceutical products including proteins peptides heparins antibiotics and advanced therapies.
• Oversees and facilitates the development of reference standards and solutions to address analytical challenges associated with biological medicines.
• Supports day to day operations of the Stability program covering the USP Biologics RS catalog inventory.
• Reviews testing history and drafts test protocols for lab submission based on designated testing requirements and schedules.
• Assists laboratories to ensure testing is completed accurately and in timely manner.
• Reviews laboratory reports evaluates results and compares to previous data and RS attributes to assess and conclude on RS/ARM suitability for use.
• Compiles current and historical data and summary assessment into Stability testing and trending reports.
• Maintains and updates various databases documenting laboratory data and program determinations on suitability and stability interval updates.
• Supports the RS Laboratory Quality Assurance and Reference Standard Evaluation with investigation of unexpected stability testing results.
• Works collaboratively with various USP departments as needed on test planning data impact assessments and appropriate determination of next steps.
• Reviews protocols and/or reports of other Scientists as assigned by manager.
• Responds to stakeholder inquiries pertaining reference standards.
• Works with Expert Committees for the development and release of reference standards.

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:

For -I

Ph.D. degree in Biochemistry Analytical Chemistry or Biological Sciences with a minimum of 7 to 10 years of post-educational work experience in recombinant therapeutic proteins peptides and carbohydrates.

Or

Biochemistry or Biological Sciences with a minimum of 11 to 13 years of commensurate industrial experience.

For Scientist-IV

Ph.D. degree in Biochemistry Analytical Chemistry or Biological Sciences with a minimum of 3 to 6 years of post-educational work experience in recombinant therapeutic proteins peptides and carbohydrates.

Or

Biochemistry or Biological Sciences with a minimum of 8 to 10 years of commensurate industrial experience with the following skill set

• Hands-on experience with analytical characterization techniques of recombinant therapeutic proteins peptides Oligonucleotides gene therapy vaccines and carbohydrates such as HPLC/UPLC LC-MS CE icIEF NMR ELISA SPR ddPCR/qPCR.
• Ability to write technical reports related to material characterization references standard evaluations and method development.
• Experience in method development and characterization of products and impurities using a variety of physicochemical techniques and biological assays.

• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with both internal and external customers.

• Knowledge of USP products and services highly desirable.

Additional Desired Preferences

• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fast-paced environment and respond to shifting priorities.
• Well-developed interpersonal negotiation and listening skills.
• Must possess the ability to multi-task and to work effectively with a team.
• Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Experience working in the compendial 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.

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 specificwritten agreement with USP.

Required Experience:

Senior IC