Senior Research Associate/Research Investigator, Cell Therapies Process Analytical Technologies
Posted on Apr 5, 2021 by Takeda Pharmaceuticals
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Research Associate/Research Investigator, Cell Therapies Process Analytical Technologies (PAT) 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Senior Research Associate/Research Investigator, Cell Therapies Process Analytical Technologies (PAT) position will play a key role in the technical evaluation and development of in-line automated analytical technologies across Takeda manufacturing platforms. Position objectives include interfacing these technologies with automated cell process equipment, analyzing output data, and addressing closure requirements to address engineering and analytical challenges in cell therapy for multiple products within the Takeda portfolio.
Independently, or with minimal supervision, plans and executes experiments and documents results. Works with supervisor as appropriate to plan and execute higher level experiments, as needed. Responsible for preparing study protocols, reports, and technology transfer documentation. Presents study results at team or department meetings.
Works with departmental and/or cross functional peers to execute on assignments, under limited supervision.
Collaborates with Data and Digital teams to provide data to map towards Digital CMC strategy and enable integration of multiple PATs.
Contributes significantly to and drives forward multiple projects within functional area.
Reviews, interprets and communicates data internally (eg, to supervisor, project teams) and prepares technical reports.
Proposes and implements resolutions to technical problems/issues.
Defines key project timelines and milestones, works with greater team to ensure deliverables are met.
Conducts experiment resource planning through experimental design, scheduling, and ordering.
Assists with the development of project strategy and communicates data/decisions within department and cross functionally as necessary.
Coordinates within departmental as well as cross functionally with peers on project work.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
To Be Considered for the Senior Research Associate Level:
Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 2+ years relevant industry experience
Master's degree or advanced degree in biology, engineering or related pharmaceutical science
Previous experience working in lab setting, benefit to have experience with cell therapy development
To Be Considered for the Research Investigator:
Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5+ years relevant industry experience
Master's degree or advanced degree in biology, engineering, or related pharmaceutical science; 3+ years relevant experience
Previous experience working in lab setting, benefit to have experience with cell therapy
Must have experience in principles and practices of cellular immunology and/or stem cell biology, including cell culture, expansion, and isolation.
Benefit to have experience in developing cell therapy or biological products, scale-up manufacturing processes, or GMP requirements.
Proficiency with data mining, data analysis and data visualization skills (GraphPad Prism, R/Python or similar) for effective and efficient data communication.
Experience with statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE and similar approaches.
Understanding of hardware/data integration requirements, particularly around the (in-line) integration of PATs to manufacturing systems such as bioreactors.
Prior experience in engaging with external partners, particularly with respect to technology evaluations, definition of URS/RFP documentation.
Previous experience with automated cell counters and flow cytometry is highly preferred.
Benefit to have knowledge of and hands-on experience with automated Cell Therapy processing tools (Bioreactors, Cell Isolation and Enrichment, etc.).
Knowledge and Skills:
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
Teamwork - Ability to work well in a highly cross-functional team environment.
Communication - Able to expresses one's self clearly and concisely within team; timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical document.
Work Ethic - Eagerness to learn new things and motivated to help other members of the team drive to project success.
Organization - Exercises good time management and prioritization skills, demonstrated to successfully multi-task.
Technical - Highly proficient in use of applicable lab equipment and operations
Resource Management - Project management skills; ability to manage one's time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors).
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.
May require approximately 5-10% travel