Takeda Pharmaceuticals Analytical Compliance/Quality Control Principal Manager in Boston, Massachusetts
Analytical Compliance/Quality Control Principal Manager
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Analytical Compliance/Quality Control Principal Manager in our Cambridge, MA location.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As an Analytical Compliance/Quality Control Principal Manager working on the Analytical Development team, you will be empowered to provide technical leadership and management of project implementation and coordination by independently planning and executing unit operations.
Prepare documentation and provides support/trouble shooting during QC testing release and stability OOS/ATI/Investigations at vendor sites
Vendor data management and leading OOS/ATI/Investigations
Interpret and communicate results and owns the technical aspects of a project
Work with departmental and/or cross functional peers to execute on assignments, under limited supervision.
Responsible for functional aspects of a project
Prepares protocols, reports to support GMP product development.
Contributes significantly to project work which may include multiple projects within functional area.
Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports.
Proposes and implements resolutions to technical GMP problems/issues
Participates as team member on GCT project teams and communicates activities from designated functional area to project team
Assists with the development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
Supports local initiatives as directed by supervisor and participates in global CMC or functional initiatives as appropriate.
Serves as a technical resource for junior staff and leverages expertise in GMPs as a functional resource/trainer.
Coordinates within departmental as well as cross functionally with peers on project work
Assist more senior managers in project management activities such as data review and electronic data management.
Ensure QC requirements are met over life cycle of assigned clinical project including GMP release, stability, retest period extensions, reference standard requalifications, specification updates, method transfers, and method validations/verifications
Support vendor audits
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Associates degree in Chemistry, Biology or equivalent with +7 years relevant industry experience
Bachelors degree in Chemistry, Biology or equivalent with 5+ years relevant industry experience
Masters degree in Chemistry, Biologiy or equivalent with 3+ years relevant industry experience
Minimum of 3 years experience in Quality Control and/or Analytical Development.
Small molecule and/or Biologics GMP drug development experience
Base Salary Range: $101,500-$145,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
- May require approximately 5% travel
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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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