Research Scientist I, OEPQT

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist I, OEPQT in our Cambridge, Massachusetts office.

OBJECTIVE/PURPOSE

As part of the Occupational, Environmental and Product Quality Toxicology team, provide toxicology risk assessments supporting Takeda’s Environmental Health and Safety (EHS) and pharmaceutical manufacturing functions that will assist with specification setting, manufacturing site selection, appropriate containment and controls, maintaining product quality attributes, and employee and patient safety.

The objective of this role is to (1) author HBEL documents and execute worker safety testing supporting the safe occupational use of our compounds/products in terms of worker exposure (2) contribute to characterizing the risk associated with environmental exposure through manufacturing, discharge, and use of our compounds/products via ERA assessments and/or PiE efforts (3) authoring toxicological risk assessments supporting product quality from impurities, contaminants, extractables/leachables, and excipients.

How you will contribute:

ACCOUNTABILITIES

• 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

Minimum Requirements/Qualifications:

• 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 is a plus
• 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
• Board certification is a plus (DABT or ERT)

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt