Posted to MedZilla on 9/18/2019


Takeda Pharmaceuticals

US-MA, Senior Quality Control Analyst Cell Therapy R0011635-MZ


 
 

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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 office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Analyst working on the IMP Quality Advanced Therapies team, you will be empowered to support internal QC testing as well as management of contract testing laboratories. and a typical day will include:

OBJECTIVES/PURPOSE:

  • The Analyst, Advanced Therapies QC Laboratory is responsible for the performance of testing of cell therapy investigational medicinal products (IMP) utilized in Takeda clinical studies.
  • This position is responsible to assist in start-up activities for the QC laboratory and qualification activities associated with the cGMP cleanrooms (Grade A-C).

ACCOUNTABILITIES:

  • Perform incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of advanced therapy drug products manufactured in the internal GMP facility.
  • Work with contract testing laboratories associated with QC testing for the advanced therapy drug products manufactured at the internal GMP facility.
  • Prepare certificate of analysis of the IMP manufactured at the internal GMP facility.
  • Ensure that testing is performed on time and as needed.
  • Assist in stability testing as needed.
  • Assist in reserve/retention sample and reference sample management.
  • 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 method transfer and method validation as needed.
  • Assist in testing, managing, data trending and report writing related to stability as needed.
  • 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 Environmental Monitoring of the internal GMP facility 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

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-LC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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