Senior Lead Investigator

Company: Takeda Pharmaceutical
Location: Salem
Posted on: May 11, 2022

Job Description:

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Job Description
About 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 discipline.
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 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. #GMSGQ #ZR1 #LI-MA1

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.

Locations
USA - MA - Alewife - BIO OPS

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Salem , Senior Lead Investigator, Other , Salem, Massachusetts