Scientist Automation and Engineering - Cell Therapies

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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? Join us as a Scientist, Automation and Engineering for our Cell Therapy group 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.

POSITION OBJECTIVES

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 focus will be evaluating and developing pre-existing and custom automated bioreactors for large-scale expansion of primary human cells for cell therapies. Position objectives include automating, streamlining, and closing process components to address engineering challenges in cell therapy for multiple products within the Takeda portfolio. This individual will independently plan and execute experiments and document results. This person is responsible for preparing study protocols, reports, and presenting study results at team or department meetings. This role works cross-functionally across development, automation, and manufacturing teams to support the definition and implementation of Takeda’s future programs and manufacturing/data platforms.

POSITION ACCOUNTABILITIES

Evaluation and development of various cell process unit operations with existing CT devices such as: CliniMACS prodigy, Sepax, Lovo, Sefia, Xuri, Quantum, or others.

Work cross-functionally across groups, workstreams and programs to provide technical support and expertise across the Cell Therapy portfolio.

Identification of key process/analytical improvement areas, with emphasis on requirements for GMP compliance.

Definition of Takeda’s Cell Therapy automation strategy, with focus on development and implementation of automated cell expansion tools.

Identify and engage key technical partners to drive project timelines for manufacturing engineering and automation solutions.

Assist in the integration and implementation of digital data enterprises, interfacing across pre-clinical, development, manufacturing and clinical groups.

Supports local and global initiatives which may include leading initiatives or work streams

Contribute to and review regulatory documents.

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.

Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 4 years relevant experience.

Bachelor's degree in chemistry, biology, pharmacy, or related pharmaceutical science and 6 years relevant experience.

TECHNICAL REQUIREMENTS

Must have 3 year of industry experience in Cell Therapy development and manufacturing. First-hand experience with GMP requirements and manufacturing is a plus.

Previous experience in and knowledge of Cell Therapy process and analytics, including both manual and automated processing solutions 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 translational aspects of 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.

Prior experience in engaging with external partners, particularly with respect to technology evaluations, URS/RFP is desirable.

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).

KNOWLEDGE AND SKILLS

Technical Skills – Experience/Expertise with 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.

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

Empowering Our People to Shine

Discover more at

takedajobs.com

No Phone Calls or Recruiters Please.

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*This job posting excludes CO applicants*

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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