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, Process and Analytical Development, Cell Therapy in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Research Investigator 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:
This Research Investigator position will play an important role in developing the clinical manufacturing processes and/or analytical methods for developing cellular therapy products. Independently, or with minimal supervision, plans and executes process and assay development, 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 complex 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 problems/issues
- May participate actively on GCT project teams by communicating activities from designated functional area to project team
- 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
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
- 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
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 expresses one s self 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 is able to 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 - Advanced proficiency in use of applicable lab equipment and operations
LINE FUNCTION SPECIFIC QUALIFICATIONS
- Experience in developing cell therapy or biological products manufacturing processes, and/or executing cellular characterization assays, including flow cytometry-based, and multiplexed luminescent readouts.
- In-depth experience in principles and practices of cell biology methodologies, cellular immunology or stem cell biology (e.g., induced pluripotent stem cells (iPSCs)), including cell culture, cell transfection and transduction, development and execution of functional in vitro and preclinical methods relevant for various types of immune cells or stem cells.
- Understanding and experience of using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in process & assay design, development, qualification and validation 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.
No Phone Calls or Recruiters Please.