Primary Activities:
- Derive/assign chemical nomenclature (IUPAC/CAS) for small molecules/biologics; validate existing names.
- Create, maintain, and curate master/reference data and descriptive metadata across the drug development lifecycle.
- Enter/update data in centralized systems; perform proofreading, validation, and data integrity reviews.
- Apply structure standardization/substance representations (SMILES, InChI, Mol files) and support normalization.
- Apply data quality rules; participate in system maintenance/SDLC and end-user acceptance testing.
- Document changes and rationale for data contracts and SOPs.
- Evaluate and pilot ML/AI/NLP approaches to assist curation (e.g., entity resolution, name generation).
- Serve as SME/point of contact for nomenclature and reference data; participate in governance and stewardship (KPIs, escalation, training).
- Ensure alignment with regulatory/industry standards (GxP, 21 CFR Part 11, ICH, IDMP, WHO Drug Dictionary). Preserve confidentiality.
Qualifications:
- Education/Experience: Degree in chemistry/chemical engineering or related field; Bachelorโs 5+ years or Masterโs/PhD 3+ years in pharma/regulated/Information Science.
Required:
- 1+ year organic chemistry; nomenclature (IUPAC/CAS) experience; structure drawing tools (ChemDraw/ACD/etc.).
- Strong domain knowledge (structures/stereochemistry/physicochemical properties/biological sequence concepts/drug development).
- Familiarity with identifiers/formats (SMILES, InChI, CAS, MOL/SDF), ontologies/taxonomies, cheminformatics tools.
- Experience with stewardship frameworks, SOPs, ownership models, KPIs; adopt new technologies (AI/ML/knowledge graphs).
- High attention to detail; excellent communication and cross-functional collaboration.