Sr Scientist I Sr. Scientist II, Documentary Standards (Excipients)

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.

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 professional highly technical non-supervisory position that supports the Excipients program unit team (PUT) within USPs Global Science and Standards Division (GSSD). The incumbent reports to a local management position at the India site as well as functionally reporting to a management position in the Excipients PUT in the US. The incumbent will support the development and technical stewardship of NF standards other scientific products outreach and awareness (in India US and internationally) and internal strategic initiatives. Key responsibilities include support for the development of missing Excipient monographs and significant revision of the existing Excipient monographs and associated reference standards (RS) in the USP-NF that will contribute to USPs success for bridging the gap in introducing missing excipient monographs and keeping existing excipient monographs current. The incumbent will utilize his or her technical expertise knowledge of excipient compendial monograph standard development process and current regulatory guidelines and strong organizational and communication skills to ensure timely development of high-quality monographs and associated reference standards. The Science EXC PUT works closely with several other departments including Strategic Customer Development (SCD)/Standard Acquisition (SA) Compendial Operation Global Laboratory Operations (GLO) Regions Program Operation (RPO) Industry Program and Global External Affairs (GEA).

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 Senior Scientist I/II has the following responsibilities:

• Works with USP staff relevant USP Excipient Expert Committee(s) (EC) subcommittees (SC) and Expert panels (EP) external stakeholders as related to Excipient monograph and RS development.
• Supports in the preparation of data packages and briefing materials to present to the Excipients EC/SC/EP; manages projects appropriately and ensures impeccable work-product delivery.
• Participates in USP EC/SC/EP meetings scientific conferences/meetings outreach visits and other events sponsored by USP and/or pharmaceutical industry trade associations and regulatory agencies and provides supporting scientific expertise at EC/SC/EP meetings internal and external meetings scientific symposia industry forums.
• Standard setting responsibilities include:
  • Prepares data summary packages briefing materials and other technical documents for correspondence with EC/CS/EP.
  • Manages action items from monthly EC /SC/EP telecom meetings.
  • Tracks and reports frequently on the status of assignments to management.
  • Facilitates the accomplishment of key departmental metrics.
• Assists in writing manuscripts for publication by USP (e.g. PF proposals stimuli articles) or in peer-reviewed journals.
• Applies knowledge of current trends in public health to prepare information for Expert Committee to facilitate decision-making.
• Performs other related duties in support of the Excipients Science Program Unit 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:

• Scientist I: Ph.D. in Organic Chemistry Analytical Chemistry Biochemistry or allied filed and 7-10 years or MS in Organic Chemistry Analytical Chemistry or Biochemistry or allied field and 11-13 years respectively of relevant experience.
• Scientist II: Ph.D. in Organic Chemistry Analytical Chemistry Biochemistry or allied field and 10-13 years or MS in Organic Chemistry Analytical Chemistry or Biochemistry or allied field and 13-15 years respectively of relevant experience.
• Candidates must have experience related to excipient composition quality or analytical chemistry as well as outstanding written and verbal communication skills in English.
• Ability to review analyze and interpret and report on data from various analytical tests such as from HPLC GC LC/MS GC/MS IR Raman UV-Vis NMR ICP-MS AA etc.

Additional Desired Preferences

• Should possess strong technical knowledge in the areas of complex molecules/compounds such as polymers fats oils waxes and plants.
• Must be able to share technical information with non-technical or non-scientific staff and to communicate effectively with representatives from pharmaceutical companies government and academic institutions. Ability to rapidly assess technical complications to identify define and solve technical issues
• Well-developed organizational interpersonal communications negotiation writing and strong listening and presentation skills.
• Proficient with pharmaceutical testing requirements and test protocols involving USP-NF compendial methods development for Excipient monographs.
• The ability to influence without direct authority.
• Results driven demonstrated with successful outcomes.
• Project Management skills and ability to prioritize tasks and manage multiple projects simultaneously.
• Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
• 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.
• Able to work flexible hours when needed.
• Prior experience in a scientific based industry.
• Excellent written and verbal communications skills

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.

Required Experience:

Senior IC