Scientist/Senior Scientist, Process Development Cell Therapy

Company: Takeda Pharmaceutical
Location: Newton Highlands
Posted on: September 25, 2022

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

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.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

POSITION OBJECTIVES

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Scientist / Senior Scientist, Process Development, Cell Therapies where you will work on CMC-driven initiatives to bring Takeda's Cell Therapy pipeline to patients. You will also play an important role in establishing and optimizing the multiple cell therapy platforms to improve the process, operational efficiency, and/or automated tools for bringing cell therapies through IND and into in-human clinical studies.

How you will contribute:

• Independently plan and implement experiments to drive the development of cell therapy processes toward manufacturing.
• Prepares study protocols, reports, technology transfer documentation, and regulatory documentation.
• Assists in defining project strategy and communicates data/decisions to the immediate team, product team, and cross-functional partners.
• Responsible for planning and resourcing the deliverables of multiple projects and/or workstreams.
• Identify and engage key technical partners to drive project timelines for manufacturing engineering and automation solutions.
• Supports local and global initiatives at project and program level. EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS
  
  Education Requirements:
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; relevant experience in cell therapy and/or automation (Scientist 0+ yrs, Senior Scientist 3+ years).
  • Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science (Scientist 4+ years, Senior Scientist 9+ years).
  • Bachelor's degree in chemistry, biology, pharmacy, or related pharmaceutical science (Scientist 6+ years, Senior Scientist 11+ years). TECHNICAL REQUIREMENTS
    • Must have 3+ year of industry experience in Cell Therapy development and/or manufacturing. First-hand experience with GMP requirements and manufacturing is a plus.
    • Experience with primary human cells is required.
    • Previous experience in and knowledge of Cell Therapy drug product development, including both manual and automated processing workflows and tools and related advantages and limitations, is preferred.
    • Experience in CAR-T, immunology, immune-oncology or vaccines with strong understanding of technical manufacturing requirements.
    • Prior experience with IND, NDA or BLA desirable.
    • Must be proficient at utilizing statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE and similar approaches.
    • Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information. KNOWLEDGE AND SKILLS
      • Technical Skills - Experience/Expertise with GMP tools, including process, 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.
                  • 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. TRAVEL REQUIREMENTS
                          • May require approximately up to 20% 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
                              In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
                              
                              Empowering Our People to Shine
                              
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                              No Phone Calls or Recruiters Please.
                              
                              EEO Statement
                              
                              Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
                              
                              Locations
                              
                              Boston, MA
                              
                              Worker Type
                              
                              Employee
                              Worker Sub-Type
                              
                              Regular
                              Time Type
                              
                              Full time

Keywords: Takeda Pharmaceutical, Boston , Scientist/Senior Scientist, Process Development Cell Therapy, Healthcare , Newton Highlands, Massachusetts