Skip to main content

Search Our Jobs

Senior Quality Control Analyst - Cell Therapy

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

Back to Job Navigation (Overview)

Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)

Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

Back to Job Navigation (Rewards)

Senior Quality Control Analyst - Cell Therapy

Apply Now
Job ID R0033180 Date posted 04/20/2021 Location Boston, Massachusetts

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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Senior Quality Control Analyst, Cell Therapy in our Cambridge Cell Therapy Manufacturing site.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QA Manager Validation Cell Therapy working on the R&D Quality team, you will be empowered to support the Facilities, Equipment and Validation Lifecycle. This position is 100% onsite and ensures compliance with applicable regulatory and Takeda specific guidance for GMP pharmaceutical operations in support of internal manufacturing of clinical-phase cell therapies

OBJECTIVES/PURPOSE:

  • The Senior QC Analyst Cell Therapy is responsible for the performance of testing of cell therapy investigational medicinal products (IMP) utilized in Takeda clinical studies.
  • This position is responsible for sample management, shipment of samples to Contract Laboratories and tracking and trending sampling data.
  • This position is responsible to assist in activities for the QC and EM laboratory and all related qualification activities such as participating in environmental monitoring performance qualifications and method transfer and verifications and validations.

ACCOUNTABILITIES:

  • 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.
  • Responsible for sample management and sending samples to Contract Laboratories. Ensure open communication to Contract Laboratories to ensure turnaround times are met.
  • Responsible for reserve/retention sample and reference sample management.
  • Responsible for data trending and report writing as assigned.
  • Assist in testing, managing, data trending and report writing related to stability as needed.
  • Assist in stability testing as needed.
  • Assist in environmental monitoring of cleanroom as needed.
  • Assist in environmental monitoring performance qualifications and method transfer and verifications and validations as needed.
  • Author, edit, and review SOPs, job aids, reports etc. as assigned.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Assist in the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.
  • Assist in maintenance, calibration and cleaning of QC equipment and instruments as needed.
  • Assist in diverse qualification activities (facility, cleaning, software etc.) as needed.
  • Assist in the Microbiology laboratory as needed.
  • Keep the QC lab clean, safe and tidy all the times.
  • Work closely and collaboratively with cross-functional team members from QA, QC, production, facility and development.
  • Additional duties as assigned.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

  • Working knowledge of Good Manufacturing Practice requirements.
  • Strong analytical knowledge and practical technical experience with cell therapy methods such as flow cytometry (FACS), q-PCR, cell count methods, and ELISA is a must
  • Experience in raw material sampling and testing
  • Experience writing specifications
  • Experience writing and reviewing SOPs for QC laboratories
  • Experience using a LIMS is a plus

Leadership

  • Excellent organizational, communication, and interpersonal skills

Decision-making and Autonomy

  • Ability to follow written and verbal directions, as well as carry out testing and tasks independently

Interaction

  • Experience working in a laboratory
  • Demonstrated ability to collaborate with others

Innovation

  • Ability to read, analyze and interpret common scientific and technical documents/information
  • Effectively presents information to management, internal groups and stakeholders.

Complexity

  • Ability to adapt to changing priorities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s Degree in Biology or another relevant field
  • Minimum of 5 years’ experience in the bio/pharmaceutical industry
  • Minimum of 3 years’ experience in GMP QC laboratory

This posting excludes Colorado applicants.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0033180
Apply Now

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map