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
- 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.