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:
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).
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
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
Experience working in a laboratory
Demonstrated ability to collaborate with others
Ability to read, analyze and interpret common scientific and technical documents/information
Effectively presents information to management, internal groups and stakeholders.
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
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