Senior Specialist, Scientific Nomenclature & Reference Data - Product

Senior Specialist, Scientific Nomenclature & Reference Data

The Senior Specialist, Scientific Nomenclature & Reference Data is an individual contributor who supports the stewardship, curation, and integration of chemical, biologic and vaccine product reference data across the drug development lifecycle. This role blends deep chemistry domain expertise, hands-on nomenclature skills, and practical master data capabilities to deliver accurate, traceable, and usable reference data for scientific, regulatory, and other business stakeholders.

The Senior Specialist will continuously improve data quality, governance, and automation approaches, so the capability remains adaptable as technologies and ways of working evolve.

Primary activities include, but are not limited to:

• Derive and assign correct nomenclature (IUPAC and CAS style as appropriate) for small molecules, biologics, and related entities; research and validate existing names for accuracy
• Create, maintain, and curate company reference/master data for substances and products, and associated descriptive metadata across the product lifecycle
• Enter and routinely update nomenclature and reference data into centralized systems; perform detailed proofreading, validation and data integrity review activities
• Define and apply structure standardization and substance representation practices (SMILES, InChI, Mol files); support structure normalization
• Understand and apply data quality rules
• Participate in system maintenance, SDLC activities, and end-user acceptance testing for reference data systems
• Understand canonical data models and metadata definitions
• Document changes & decision rationale for data contracts and SOPs for master/reference data
• Evaluate ML/AI or NLP approaches to assist curation (e.g., entity resolution, name generation, property prediction)
• Support or lead projects and pilots to improve efficiency, data quality, and usability; identify and implement process improvements
• Serve as subject matter expert and point of contact for chemical and scientific nomenclature and reference data issues; build and maintain strong relationships with end users and stakeholders across functions
• Participate in governance forums; help establish stewardship models, KPIs (completeness, accuracy, timeliness), escalation paths, and training for data producers/consumers
• Ensure practices reflect relevant regulatory and industry standards (GxP, 21 CFR part 11, ICH, IDMP, WHO Drug Dictionary) and maintain up-to-date knowledge of nomenclature and data standards
• Preserve confidentiality and adhere to company policies governing information disclosure

Qualifications:

Education and Experience:

• Degree in chemistry, biochemistry, molecular biology, or related scientific disciplines that combine chemistry and biology, plus pharmaceutical industry, regulated industry, or Information Science experience - Bachelor's and 5+ years, Master's/PhD and 3+ years

Required:

• Completed at least one year of organic chemistry
• Experience or familiarity with deriving chemical nomenclature (IUPAC or CAS style)
• Experience with structure drawing software (Chem Draw, ACD, Accerlys, etc.)
• Domain expertise:
  Strong knowledge of chemical structures, stereochemistry, physicochemical properties, biological sequence representations and concepts, and the drug development process
• Familiarity with chemical identifiers and formats (SMILES, InChI, CAS, MOL/SDF), spectral data concepts, chemical ontologies/taxonomies, and common cheminformatics tools or libraries
• Experience establishing stewardship frameworks, SOPs, ownership models, and KPIs to maintain high quality, traceable, and compliant data
• Demonstrated history of adopting new technologies (AI, ML-assisted curation, knowledge graphs) and willingness to learn & prototype new approaches
• Very organized and able to work with high attention to detail
• Excellent written and verbal communication skills with the ability to convey technical and business information
• Ability to present in a group environment
• Strong time management and project management skills
• Ability to balance and prioritize multiple tasks
• Ability to work under pressure in a changing environment with flexibility
• Ability to work independently to drive tasks to completion and to act with appropriate accountability
• Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team

Preferred qualifications:

• Experience with searching resources (Sci Finder, STN) and familiarity with structure searching.
• Data modeling & metadata:
  Ability to understand canonical data models for products, substances and related metadata, with understanding of identifiers, keys, versioning, and provenance.
• Familiarity with data standards and ontologies used in the biomedical/pharma domain (WHO Drug, MedDRA, CDISC, MESH, UMLS).
• Experience with database querying (SQL), and data visualization tools
• Proficiency with programming languages, such as python or R
• Skilled at defining validation rules,…