Job Title
Senior Scientist I / Senior Scientist II – Small Molecules (Chemical Information & GSRS)
Work Mode
Onsite / Office-Based
Reporting To
Senior Manager – Small Molecules Department
Organization
United States Pharmacopeia (USP) (USP–India)
About USP
United States Pharmacopeia (USP) is a global scientific organization committed to developing trusted public standards that ensure the quality, safety, and efficacy of medicines worldwide. USP fosters inclusive scientific collaboration, regulatory excellence, and evidence-based decision-making to strengthen global healthcare systems and improve patient outcomes.
For more information, visit: United States Pharmacopeia
Job Summary
We are seeking an experienced Senior Scientist (I/II) to support the Small Molecules Department in the creation, validation, and management of chemical structure information used in pharmacopeial monograph development.
The role involves working with chemical databases, structure files, and informatics platforms (including GSRS) to ensure accurate, standardized chemical information supporting drug substance and dosage form monographs in USP–NF.
This is an independent contributor role requiring strong expertise in organic chemistry, cheminformatics tools, and regulatory scientific documentation.
Key Responsibilities
Chemical Data Creation & Management
Create and update chemical information files based on sponsor and external submissions.
Develop and maintain accurate chemical structure records for monograph development.
Ensure consistency, accuracy, and compliance with internal USP standards.
Data Review & Validation
Review and validate chemical data for scientific accuracy and completeness.
Ensure compliance with internal data standards and pharmacopeial requirements.
Perform quality checks on chemical information prior to publication or use.
Cheminformatics & Tool Usage
Use GSRS (Global Substance Registration System) for chemical data management.
Work with tools such as ChemDraw and ISIS for structure creation and editing.
Conduct chemical database searches using SciFinder, ChemSpider, USAN, INN, PubMed, Reaxys, and PubChem.
Scientific Collaboration
Collaborate with Small Molecules teams, Reference Standards Scientists, ADL, RSD, GSRS, and Publications teams.
Support cross-functional initiatives related to monograph development and chemical data integration.
Communicate with internal and external stakeholders including regulatory bodies and pharmacopeias.
System Integration & Support
Work with IT and data science teams for integration of chemical data systems.
Support enterprise-level chemical information platforms and workflows.
Literature & Patent Research
Perform scientific literature and patent searches to support chemical data validation.
Analyze and interpret chemical information from multiple scientific sources.
Additional Responsibilities
Participate in cross-functional scientific projects and strategic initiatives.
Contribute to continuous improvement of chemical information workflows.
Perform additional duties as assigned to support departmental goals.
Required Qualifications
Education & Experience
MSc in Organic Chemistry or related field:
11–13 years experience (Senior Scientist I)
13–15 years experience (Senior Scientist II)
OR PhD in Organic Chemistry or related discipline:
7–10 years experience (Senior Scientist I)
10–13 years experience (Senior Scientist II)
Required Skills & Competencies
Technical Expertise
Strong expertise in organic chemistry and reaction mechanisms.
Experience in chemical structure creation and validation.
Proficiency in IUPAC nomenclature.
Strong understanding of degradation chemistry of organic compounds (preferred).
Cheminformatics & Tools
Experience with GSRS platform (preferred).
Proficiency in ChemDraw or similar structure-drawing tools.
Experience with chemical databases (SciFinder, ChemSpider, PubChem, Reaxys, etc.).
Regulatory & Scientific Knowledge
Understanding of pharmacopeial standards and monograph development (USP or global pharmacopeias preferred).
Familiarity with pharmaceutical industry practices.
Knowledge of regulatory and chemical data standards.
Analytical & Communication Skills
Strong analytical and problem-solving abilities.
Excellent scientific writing and documentation skills.
Ability to collaborate across scientific and technical teams.
Strong stakeholder communication skills.
Behavioral Competencies
Strong attention to detail and scientific rigor.
Ability to work independently as an individual contributor.
Strong ownership and accountability for deliverables.
Collaborative mindset in cross-functional environments.
Preferred Experience
Experience with pharmaceutical industry chemical data systems.
Exposure to biologics and excipients (added advantage).
Experience working with global pharmacopeial organizations.
Working Environment
Office-based scientific role with cross-functional collaboration.
Exposure to global scientific, regulatory, and informatics teams.
High focus on data accuracy, compliance, and scientific integrity.
Why Join USP
Contribute directly to global public health standards and medicine quality.
Work with advanced chemical informatics systems and global databases.
Collaborate with international scientific and regulatory experts.
Be part of an inclusive organization focused on scientific excellence and equity.
Play a key role in shaping pharmacopeial monographs used worldwide.
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Kyiv |Lima Region :
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