Takeda · 5 hours ago

Research Scientist I, OEPQT

Boston, MA

Full-time

Remote

Mid, Senior Level

$108K/yr - $170K/yr

6+ years exp

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Responsibilities

Author toxicology risk assessments for impurities, extractables and leachables, contaminants, excipients, and in silico mutagenicity assessments for drug manufacturing functions

Presents risk assessments to cross-functional colleagues in support of Quality investigations or to highlight potential development risks with guidance from senior team members

Execute Environmental Risk Assessments or worker safety studies to support regulatory filings and corporate EHS with guidance from senior team members

Author PDE monographs and occupational exposure limits (OELs) in support of EHS and Quality interfaces

Provide SME support to complete CMO Questionnaires supporting external manufacturing of Takeda R&D and marketed products

Contributes ideas to improve OEPQT processes and documentation practices

Interprets results of complex analyses or experiments

Qualification

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Toxicology risk assessmentsEnvironmental Risk AssessmentsRelevant disciplinePharmaceutical setting experienceScientific knowledge in toxicologyBoard certification DABTBoard certification ERTTime management skillsCollaboration skills

Required

Ph.D. in biology, biochemistry, pharmacology, toxicology, public health, or a related discipline, or MS. with 6+ years, or BS with 8+ years of experience

Previous experience in a pharmaceutical setting providing toxicology risk assessments

Scientific knowledge in toxicology and pharmacology

Attention to detail in written work and planning experiments/studies

Self-motivated with strong time management and organizational skills

Ability to balance multiple projects and flexible with changing priorities

Good collaboration and communication skills working in team environments and in matrixed-management settings