Takeda Pharmaceuticals Manufacturing Lead Investigator in Boston, Massachusetts
Job Title: Manufacturing Lead Investigator
Location: Cambridge, MA
About the role:
You will lead evaluation and close out of deviations within the established timelines. You will also evaluate and close out Environmental Monitoring excursions and Metrology Out of Tolerance assessments.
This is a hybrid role that will report to the Manufacturing Compliance Manager.
How you will contribute:
Investigate and document findings and impact assessment for deviations mostly minor, some major.
Provide subject matter expertise on manufacturing process to support deviations owned by other departments.
Author calibration Out of Tolerance (OOT) impact assessments and Environmental Monitoring (EM) excursions impact assessments.
Participate in continuous improvement initiatives.
Resolve process related issues of low to mid- level complexity, occasionally lead/resolve complex problems.
Strives to create novel and innovative solutions to issues.
Actively participates on cross functional teams with internal/external SMEs.
Assist assigned functional area leads in driving problems to resolution with minimal supervision.
Represent team on projects and investigations with internal contacts including Manufacturing, QC / QA, and Support departments (Engineering, Facilities, Validation, Process Development, etc.)
Be an external spokesperson during Health Agency Inspections on minor matters pertaining to investigations..
What you bring to Takeda:
Bachelor's in Science, Engineering or a related discipline.
2-5 years related experience in the manufacturing or development of biologics or pharmaceuticals.
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
Professional training and development opportunities
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
This posting excludes Colorado applicants.
#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid
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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