Senior Scientist, Process & Analytical Development - Cell Therapy
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, Process & Analytical Development - Cell Therapy 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 Sr. Scientist, Platform and Product Development, working on the Pharmaceutical Sciences, Cell Therapy team, you will be empowered to build a world-class cell therapy team.
This Senior Scientist position will play an important role in developing the clinical manufacturing processes and/or analytical methods for developing cellular therapy especially CAR-T and CAR-NK products. Develops project or significant technical strategy within area of expertise. Leverages technical skill(s) as a resource/expert within the department. Independently plans and executes process development, characterization, and qualification studies. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials.
Drives 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 areas.
Plans and implements resolutions to technical problems/issues
Assists with the development of project strategy and communicates complex data/decisions within the 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, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
PhD in Immunology, biology, biomedical engineering or related pharmaceutical science; 3+ years relevant industry experience
Demonstrated mastery of subject or area related to Natural Killer cell biology, viral production and transduction, and gene editing technology
Knowledge and Skills:
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions
Teamwork -- Ability to work well on global cross-functional teams.
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 with senior management; technical writing skills to support authorship and approval of internal technical documents
Organization - Exercises good time management and prioritization skills to balance multiple project and departmental objectives
Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors
Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
Resource Management -Project management skills; ability to manage one's time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
Leadership Skills - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
May require approximately 5-10% travel
LINE FUNCTION SPECIFIC QUALIFICATIONS:
Experience in developing cell therapy manufacturing processes, or experience in developing cell therapy product, especially in natural killer cell therapy
In-depth experience in principles and practices of cell biology methodologies and cellular immunology
Experience in immune cell culture, cell transfection and transduction, development and execution of functional in vitro and preclinical methods relevant for various types of immune cells.
Understanding of viral transduction principles and processes is strongly preferred
Experience with gene editing technology, such as CRISPR/Cas9, is strongly preferred
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.
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