Research Scientist I, OEPQT

Company: Takeda Pharmaceutical
Location: Boston
Posted on: November 12, 2024

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout 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/PURPOSEAs 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 experimentsMinimum 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 SummaryWe 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:Boston, MAU.S. Base Salary Range:108,500.00 - 170,500.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.---The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. -U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. -EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYes

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