Senior Lead Investigator
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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 DescriptionAbout the role:Join Takeda as a Senior
Lead Investigator where you will lead investigation teams to
identify root cause, evaluate technical impact, and provide
recommendations on batch disposition for deviations of complexity.
You will support EMs and OOTs. You will report to the
Investigations Manager where you will provide subject matter
expertise on manufacturing process to support deviations owned by
other departments. You will lead continuous improvement projects.
You will be and external spokesperson during Health Agency
Inspections on major matters of investigations. You will work with
internal functions and senior internal personnel on matters.
Internal contacts include: Manufacturing, QC/QA, Support
departments (Engineering, Facilities, Validation, Process
Development), and Regulatory/ Qualified Persons/ Product Quality
Management.How you will contribute:
- You will show capability to resolve the majority of complex
issues and escalation.
- With supervisory guidance defines areas outside of personal
expertise and identifies/ involves internal and cross functional
subject matter experts and external consultants/SMEs.
- Regardless of format, you will allow the end-user, specifically
QA personnel and regulatory inspectors, to arrive at the intended
conclusions and you will update team members.
- You will demonstrate / facilitate group discussions in a
constructive and positive direction.
- You will identify potential sources of conflict and resolve
independently or escalates promptly.What you bring to Takeda:
- Bachelor's in Science, Engineering or a related
- 5 years of related experience in the manufacturing or
development of biologics or pharmaceuticals.
- You will have previous technical writing experience and
interpreting technical drawings/reports.
- You will be familiar with basic statistical analysis, Lean/6
sigma approaches, and basic Project Management skills.
- You will have Trackwise or, equal system; Microsoft Visio,
Project, and SharePoint.
- LIMS, SAP, OSI/PI.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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementMore 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.
#GMSGQ #ZR1 #LI-MA1EEO 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.LocationsUSA - MA - Alewife - BIO
OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Salem , Senior Lead Investigator, Other , Salem, Massachusetts
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