Senior Specialist, Scientific Nomenclature & Reference Data Product

Job Description

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 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 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 chemical engineering or related scientific discipline plus pharmaceutical industry regulated industry or Information Science experience - Bachelors and 5 years Masters/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 (ChemDraw 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 chemical searching resources (SciFinder 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 implementing automated checks resolving duplicates/merges and maintaining robust audit trails.

• Knowledge of how GxP GLP 21 CFR part 11 REACH and IDMP standards influence data management practices

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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