Research Investigator/Senior Research Associate, Process Development - Cell Therapies
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Research Investigator/Senior Research Associate, Process Development - Cell TherapiesApply Now
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 Research Investigator/Senior Research Associate, Process and Analytical Development - Cell Therapies in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Research Investigator/Senior Research Associate working on the Cell Therapy team, you will be empowered to assist in the development of cellular therapy products and work on cross-functional teams, and a typical day will include:
The Research Investigator/Senior Research Associate will play an important role in developing processes and/or methods for cell therapy products, focusing on addressing the scientific and engineering challenges to large-scale clinical manufacturing. This role will apply knowledge from upstream biologics, vaccines, or viral vector manufacturing, and will integrate bioreactors and automation technologies into the cell therapy processes of the future.
Independently, or with minimal supervision, plans and executes process, characterization and qualification studies. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Presents study results at team or department meetings, to external partners or at conferences.
- Works with departmental and/or cross functional peers to execute on assignments, under limited supervision.
- Owns responsibility for technical aspects of a project.
- Prepares experimental protocols.
- Contributes significantly to project work which may include multiple projects within functional area.
- Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports.
- Proposes and implements resolutions to technical obstacles.
- Designs experiments/unit operations independently including follow up experiments as necessary.
- Assists with the development of project strategy and communicates complex data/decisions within department and cross-functionally as necessary.
- Supports local initiatives as directed by supervisor and participates in global CMC or functional initiatives as appropriate.
- Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
- Coordinates within departmental as well as cross functionally with peers on project work.
- Supports technology transfer through writing and consolidating technical documents.
EDUCATION, EXPERIENCE AND SKILLS:
To Be Considered for the Research Investigator Level:
- Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 7+ years relevant industry experience
- Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5+ years relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience,
- Previous experience working in lab setting
To Be Considered for the Senior Research Associate Level:
- Bachelors degree in chemistry, biology, engineering or related discipline; 2+ years relevant industry or academic experience
- Masters degree in chemistry, biology, engineering or related discipline; 0+ years relevant industry or academic experience
- Previous experience working in lab setting, or Masters degree plus appropriate laboratory training.
Knowledge and Skills:
- Analytical and Problem-Solving Skills: Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
- Teamwork: Ability to work well in a highly cross-functional team environment.
- Communication: Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical documents.
- Organization: Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously.
- Knowledge Sharing: Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
- Technical: Proficient in use of applicable lab equipment and operations.
LINE FUNCTION SPECIFIC QUALIFICATIONS
- Proficient with mammalian cell culture and aseptic techniques. Experience culturing T cells is a plus.
- Experience with laboratory-scale bioreactor operation and other instrumentation that supports cell culture (metabolite analyzers, etc.). Experience with scale-up of manufacturing processes.
- Ability to work on a fast-paced, cross-functional team.
Preferred Qualifications (not required):
- Experience in developing cell therapy and/or biological products, including the scale-up of these manufacturing processes. Cell Therapies, Biologics, Vaccines, or Viral Vector Upstream Process Development experience is helpful.
- Experience with fed-batch, perfusion, and/or continuous mammalian cell culture processes used in the production of protein-products, vaccines, viral vectors, etc.
- Experience with cell retention devices (ATF), counter-flow centrifugation (kSep, Rotea), acoustic separation (Cadence, ekko), automated cell processing machines (LOVO, Sepax, Sefia), gravity settlers, spinning membrane filtration, etc.
- Experience in principles and practices of cellular immunology and/or stem cell biology, including cell transfection, transduction, and immune cell expansion.
- Experience with iPSC or ESC differentiation into various cell lineages.
- Understanding the fundamentals of media formulation is a plus.
- May require approximately 5% travel.
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.
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Job ID R0021816