Manufacturing Lead Investigator
Company: Takeda Pharmaceutical
Location: Boston
Posted on: April 25, 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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionJob Title: Manufacturing Lead
InvestigatorLocation: Cambridge, MAAbout the role: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.How you will contribute:
- 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 investigationsWhat you
bring to Takeda:
- 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 plusImportant
Considerations: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.#GMSGQ #ZR1
#LI-MA1Takeda 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:$67,900.00 - $106,700.00The 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 time
Keywords: Takeda Pharmaceutical, Chelsea , Manufacturing Lead Investigator, Other , Boston, Massachusetts
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