Takeda Pharmaceutical Company Limited.
Boston, MA, United States
Chemistry, Sciences, Engineering
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Engineering and Automation Development Lead within the Cell Therapy team at our Cambridge office.
Here, everyone matters, and you will be a vital contributor to our inspiring bold mission. As an Engineering and Automation Development Lead you will be empowered to provide scientific expertise and work with internal stakeholders as well as external partners across multiple functions at Takeda.
In addition to managing Takeda’s commercial cell therapy assets, the Cell Therapy Pharmaceutical Sciences team is developing several novel programs and pursuing them towards in-human clinical studies. This position’s primary role is to provide technical leadership on process automation and engineering development across Takeda’s programs, and you will be expected to contribute to the definition of Takeda’s Cell Therapy manufacturing strategy. In this role you will work in conjunction with the Development, Technical Operation and Quality teams to support the definition and implementation of Takeda’s current and future programs.
Lead for development and optimization of automated process solutions to be deployed across Takeda’s Cell Therapy processes
Work cross-functionally with the Analytical&Process Development groups to identify of key process gaps/improvement areas, particularly as it concerns to ensure process control and GMP compliance
Accountable for definition of engineering strategy towards technical gaps mitigation
Work cross-functionally with Manufacturing, Technical Operations and Regulatory teams to define Takeda’s life cycle management strategy, and lead the qualification and implementation of new enabling technologies
Support both Development and Technology Transfer activities, including transfer from/to external partners and CMOs
Management and definition of internal as well as external technical alliances, including vendors, technology providers and manufacturing partners
Identify key technical partners and drive contractual negotiations, RFPs, project timelines and overall engagement of technical partners for manufacturing engineering and automation solutions
Supports local and global initiatives which may include leading initiatives or work streams
Contribute to and review regulatory documents
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 7 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; 3 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 have advanced knowledge of and hands-on experience on automated Cell Therapy processing tools
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
Must be familiar with process qualification requirements, as well as with GMP Change Control requirements.
Must have prior experience with technology transfer, batch record editing, as well as training.
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 CART, 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 development of automated cell processing solutions, as well as engineered solutions for cell therapy applications.
Teamwork Skills – Demonstrated ability to work well on global cross-functional teams. Experience in operating and executing programs in GMP environments.
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 designing and authoring test plans, qualification studies, as well as experience with leading small teams and training.
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. Background in GMP manufacturing is required.
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)
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 5% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com