Scientist, Platform & Product Development, Cell Therapies
Posted on Apr 6, 2021 by Takeda Pharmaceuticals
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist, Platform & Product Development, Cell Therapies in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Scientist, Platform & Product Development, Cell Therapies working on the Pharmaceutical Sciences, Cell Therapy team, you will be empowered to build a world class cell therapy team.
This scientist position will play an important role in developing the clinical manufacturing processes and/or analytical methods for developing cellular therapy products. Independently 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.
Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
Contributes significantly and independently to project work which may include multiple projects within functional area.
Reviews, interprets and communicates data cross-functionally within CMC and/or project teams.
Plans and implements resolutions to technical problems/issues
Represents functional area on GCT project teams by communicating activities from designated functional area to project team
Supports local and global initiatives which may include leading initiatives or work streams
Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
Independently designs and executes experiments, and reports results
Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team.
Responsible for integrating scientific/technical efforts around cross-functional issues.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
Education and Experience:
PhD in chemistry, biology, pharmacy, chemical or biomedical engineering or related pharmaceutical science; 0+ years relevant industry experience
Sound knowledge of current Good Manufacturing Practices (cGMP)
Previous experience with the use of contract facilities
Experience in working in a multi-disciplinary team environment
Demonstrated mastery of subject or area related to field
Knowledge and Skills:
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
Communication Skills -Able to expresses one's self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of 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
Resource Management -Ability to manage one's time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
Technical - Subject matter expertise and knowledge of applicable lab equipment and operations.
May require approximately 5-10% travel
LINE FUNCTION SPECIFIC QUALIFICATIONS:
Experience in developing cell therapy or biological products manufacturing processes, or experience in developing and 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 (eg, 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.
Understanding of viral transduction principles and processes is strongly preferred
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
At least 2-4 years of biopharmaceutical industry experience in a development setting is preferred.