Associate Director CMC Cell Therapy

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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.

OBJECTIVES/PURPOSE

• Definition of process development roadmap for cell therapy assets, particularly towards product/biology optimization
• Management of CMC technical teams and activities
• Assists in defining project strategy and communicates data/decision to immediate team, product team, and cross-functional partners.
• Responsible for planning and resourcing deliverables of multiple projects and/or workstreams.

Join the Cell Therapy Process Development team as an Associate Director where you will work on CMC-driven initiatives to bring Takeda’s Cell Therapy pipeline to patients. You will lead the process/product development and characterization of the cell process to establish new manufacturing workflows for multiple products within the Takeda portfolio. This Associate Director will work within a cross-functional team of engineers and biologists focused on delivering cell rpcoesses to enable first-in-human clinical trials, INDs, and life cycle management for various cell therapies within the pipeline.

• Must have Ph.D (preferred)/M.Sc. in Biotechnology, Immunology or related-field. In-depth knowledge of T-, NK-T, and gd-T cells is sought.
• Must have 5-10 years industry experience in Cell Therapy development and/or manufacturing. First-hand experience with GMP manufacturing is a plus.
• Must display excellent communication skills, and be proficient in utilizing statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE or similar approaches.
• Must have experience working with departmental and/or cross functional peers to coordinate and execute on complex projects.
• Previous experience with INDs and BLAs is preferred.

ACCOUNTABILITIES

• Establishes project direction by integrating science, technical knowledge, and program objectives.
• Establishes and drives creation of cross departmental strategy to deliver Process Lock, IND, and beyond
• Contributes to the preparation, editing, and review of regulatory documents
• Contributes to the development of team culture and capabilities
• Responsible for budgeting and headcount (FTE) mapping for success of projects
• Interprets and analyzes data, helping to incorporate results into overall scientific projects; Independently generates novel hypothesis
• Responsible for the development of direct reports and mentors lab members in experimental design and execution
• Demonstrates in-depth technical knowledge within discipline and well-developed knowledge of other disciplines/departments related to program/project scope
• Demonstrates strong project management skills to organize, track, and facilitate project/program goals
• Leads scientific thought and decision making within multiple projects and/or program
• Manages 2-3 direct reports
• Idependently manages workload and expectations
• Scientific driver for development strategy that delivers program needs and impacts group within and outside of function
• Initiates and leads extermanl interactions and collaborations
• Collaborates with other departments, acting as subject matter expert in Process Development
• Determines methods on new assignments
• Makes strategic recommenations on projects

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• PhD in a scifentific discipline with 5-10 years relevant industry experience
• MS in a scientific discipline with 11+ years relevant industry experience
• 5+ years of industry experience required
• 3+ years of people management experience required

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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.

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

Base Salary Range: 143,500.00 to 205,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

Empowering Our People to Shine

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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.