US-MA, Senior Scientist, Cell Therapy Automation R0013229-MZ
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist, Cell Therapy Automation in our Cambridge 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 Futureto people around the world.
The Cell Therapy Pharmaceutical Sciences team is pursuing several programs towards in-human clinical studies, in addition to managing Takeda s commercial cell therapy assets. This position s primary role is to provide technical leadership in bringing these programs to patients, with particular focus on process and analytical engineering, automation and digital enterprises. In this role you will be expected to contribute to the definition of Takeda s Cell Therapy manufacturing strategy, working cross-functionally across development, automation and manufacturing teams to support the definition and implementation of Takeda s future programs and manufacturing/data platforms.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 10+ years relevant experience
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5+ years relevant experience
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 2+ years relevant experience
Must have 5+ year of industry experience in Cell Therapy development and manufacturing, including 2+ years first-hand experience with GMP requirements and manufacturing
Must display advanced knowledge of Cell Therapy process and analytics, including both manual and automated processing solutions and related advantages and limitations
Prior experience with both internal and external manufacturing (CMOs), with demonstrated Technology Transfer expertise and well as Life Cycle management (process change and change control)
Must be proficient at utilizing statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE and similar approaches
Prior experience in engaging with external partners, particularly with respect to technology evaluations, URS/RFP
Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information
Experience in working in conjunction with engineering and automation department to deliver phase-appropriate manufacturing solutions (including custom solutions)
Experience in CAR-T, immunology, immune-oncology or vaccines with strong understanding of technical manufacturing requirements
Prior experience with translational aspects of IND, NDA or BLA desirable
Knowledge and Skills:
Technical Skills SME for GMP tools, including process and analytics and GMP manufacturing.
Teamwork Skills Demonstrated 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
Portfolio Management / Stakeholder Management Demonstrated experience in leading and managing internal and external partner and vendor relations
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. Prior experience in URS, RFP and custom engineered solutions.
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 up to 20% travel
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
Discover more at takedajobs.com
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