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Quality Control Analyst, Cell Therapy

Boston, Massachusetts
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0113218 Date posted 02/09/2024 Location Boston, Massachusetts

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Job Description

Job Title: Quality Control Analyst, Cell Therapy

Location: Cambridge, MA

About the role:

As the QC Analyst Cell Therapy, you will ensure the performance of testing of cell therapy investigational medicinal products (IMP) utilized in Takeda clinical studies. You will assist in activities for the QC laboratory from ordering, to inventory management, to raw material and sample management, to equipment calibration, cleaning and maintenance. You will also assist in the digital transformation of the QC laboratory.

This is a fully on-site role that reports to the Associate Director Advanced Therapies Quality.

How you will contribute:

  • Perform incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of cell therapy drug products manufactured in the internal GMP facility.
  • Perform sample management and send samples to contract laboratories.
  • Perform cleaning, calibration, and maintenance of laboratory equipment and instruments.
  • Assist in the digital transformation of the QC laboratory, maintaining data integrity and ensuring compliance with company SOPs, specifications and cGMP regulations.
  • Trend data, author, edit, and review SOPs, job aids, reports, and others as assigned.
  • Assist in stability testing, method transfer, method qualifications and verifications as assigned..
  • Assist in the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.
  • Assist in diverse qualification activities (facility, cleaning, software) assigned.
  • Keep the QC lab clean, safe and tidy all the times.
  • Work with cross-functional team members from QA, QC, production, facility and development.
  • Additional duties as assigned.

What you bring to Takeda:

  • Bachelor's Degree in Biology, Microbiology, Chemistry or related field
  • 2+ years of experience in cGMP Quality Control or Microbiology

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
  • Professional training and development opportunities
  • Tuition reimbursement

Important Considerations

This role supports biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive). 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.

This posting excludes Colorado applicants.

#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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Working at Takeda

  • Inclusion

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  • Collaboration

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Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

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  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

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Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Boston, Massachusetts


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