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Job Title: Manufacturing Lead Investigator

Location: Cambridge, MA

With support the Lead Investigator will lead evaluation and close out of deviations within the established timelines. Will also evaluate and close out Environmental Monitoring excursions and Metrology Out of Tolerance assessments.

• Conduct investigations of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors to determine product impact, identify cause, and identify corrective and preventative actions.

• Build productive working relationships throughout the organization.

• Investigate and document findings and influence 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
• Author Environmental Monitoring (EM) excursions impact assessments
• Participate in continuous improvement initiative
• Strives to create fresh solutions to issues.
• Actively participate on teams with internal/external SMEs.
• Assist assigned functional area leads in driving problems to resolution.
• Serves as external spokesperson during Health Agency Inspections on minor matters pertaining to investigations

• Bachelor's in Science, Engineering or a related discipline
• 2-5 years related experience in the manufacturing and development of biologics or pharmaceuticals
• Previous technical writing experience is ideal
• Provides clear, concise and technically sound written & verbal communications in a timely manner with limited input from manager or senior team members
• Seeks to identify sources of conflict and resolve independently or under the guidance of senior team members / managers.
• Proficient with the following software applications including Microsoft Visio, Project, and SharePoint TrackWise, or equivalent system. LIMS, SAP, OSI/PI applications a plus

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.

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.

#GMSGQ #ZR1 #LI-MA1

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:

The 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 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 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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