• Job Description

  Req#: R0102080

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  Job Description

  About the role:

  At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

  Join Takeda as a Scientist CMC Cell Therapy Analytical Development where you will play an important role in developing analytical assays for cellular therapy, e.g. CAR T and CAR NK products, etc. You will also independently plan and execute analytical development studies for cell therapy drug products, plasmid, viral vectors, and cell bank testing.

  How you will contribute:

  • You will prepare study protocols, reports, technology transfer documentation, and regulatory documents for IND/INDa/BLA filings

  • You will present study results at team or department meetings, to internal and external partners and stakeholders

  • Support cell therapy analytical development for clinical stage programs

  • Independently lead aspects of viral vector (retro/lenti) and cell bank release assay development, characterization, qualification and transfer, with a focus on cellular and molecular technology platforms

  • Perform experimental studies independently; review, interpret, and communicate data internally and cross-functionally within CMC and/or project teams

  • Plan troubleshooting exercises and implements resolutions to technical problems/issues

  • Good documentation of experimental data in electronic lab notebooks

  • Draft methods, study protocols and reports. Author and review analytical sections in regulatory filing documents

  • Lead protocol driven assay transfer to QC laboratory and CROs.

  • Trend assay performance and troubleshoot assays internally and at QC/CROs as needed.

  • Understands project timelines, deliverables, and plans. Coordinates project work accordingly with departmental, functional, and external vendors or stakeholders

  • Experience in developing analytical assays for cell therapy or biological products, or experience in developing and executing cellular characterization assays such as PCR, ELISAs, cell-based potency assays, flow cytometry, etc.

  • Understanding viral transduction principles and processes is strongly preferred

  • Experience in viral vector and cell assay development and tech transfer is highly desirable.

  • Understanding of various cell and gene therapies, and gene editing technologies associated with CAR T or CAR NK products.

  • Knowledge of industrial standard practice in assay development and qualification including familiarization with ICH guidelines and GMP regulations

  • Understanding and experience in using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in assay design, development, qualification, and validation.

  • Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO, or tech transfer of product release & characterization or clinical assays to a CRO, or other third party is a plus.

  Minimum Requirements/Qualifications:

  • PhD in biology, biomedical science, immunology, pharmaceutical science or related field, or Master degree with 4+ years relevant experience or Bachelor degree with 6+ years relevant experience.

  • Prior experience in mammalian cell culture, ELISA, flow cytometry and/or PCR based assays is required

  • Prior experience with cellular potency assay for cell therapy or biological therapeutics is desirable

  • Prior experience with Next-Gen sequencing methods is a big plus

  • Experience in working in a multi-disciplinary team environment

  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

  • Flexible Ways of Working

  • Tuition reimbursement

  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.

  In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

  #LI-AA1

  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

• About the company

  Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

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