About the role:
Toxicologist - Nonclinical Safety Assessment, Scientist
This position is for a toxicologist in the Drug Safety Research and Evaluation (DSRE) group at Takeda, located in Cambridge, MA. In this role the candidate will complete toxicology risk assessments supporting Environmental Health and Safety (EHS) and manufacturing functions within Takeda. This includes toxicology support for impurity qualifications, extractables and leachables, environmental risk assessments (ERA), permitted daily exposure limits (PDEs), and other health-based exposure limits (HBELs).
This position will support programs across Takeda s therapeutic areas: oncology, gastroenterology, neuroscience, rare diseases, plasma derived therapies, and vaccines, and across all stages of development from early discovery to marketed products. The assessments will involve a broad range of modalities that include small molecules, protein therapeutics, oligonucleotides, and cell and gene therapies. In this role the candidate is expected to be able to work with minimal supervision on toxicology product risk assessments and be familiar with regulatory guidances and industry trends as they relate to assessments supporting manufacturing and EHS activities. Since manufacturing sites are located globally, good communication skills are necessary to navigate for effective issue resolution and for efficient response across the varying time zones. The ideal candidate will have experience writing regulatory responses for health authorities not only for toxicology product risk assessments but also general pharmaceutical drug safety. The person must be scientifically independent and able to articulate implications and risks from toxicology assessments to a broad audience.
Join Takeda as a Toxicologist - Nonclinical Safety Assessment, Scientist , based in Cambridge, MA.
How you will contribute:
- Provide toxicology product risk assessments for impurities, extractables and leachables, and in silico mutagenicity assessments for drug manufacturing functions
- Plan and oversee Environmental Risk Assessments or worker safety studies to support regulatory filings and corporate EHS
- Provide toxicology components of PDEs, occupational exposure limits (OELs) and other HBELs in support of EHS interface
- PhD in toxicology or related discipline, or MS with 6+ years relevant experience, or BS with 8+ years relevant experience
- Previous experience in a pharmaceutical setting providing toxicology risk assessments is a plus
- Attention to detail in written work and planning experiments/studies
- Good collaboration and communication skills working in team environments and in matrixed-management settings
- Board certification is a plus (DABT or ERT)
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type