Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist, Process Engineering - Cell Therapies 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 Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Cell Therapy Pharmaceutical Sciences team in Cambridge, MA, is establishing internal capabilities to manufacture several parallel cell therapy programs for in-human clinical studies.
This position s primary role is to provide scientific and technical input in bringing these programs to patients, with particular focus on qualification and optimization of processes methods that will deployed in manufacturing.
In this role you will be expected to work within the GMP Manufacturing Engineering (GME) group, working with Development, Technical Operations and Quality to onboard new processes and instrumentation, and engineer them towards robust deployment and implementation in GMP.
- Act as the SPOC for the interface with technical development organization to define and implement new technical standards for existing and new technologies and equipment.
- Independently design and execute experiments to support tech transfer and process method development
- Develop and implement validation policies to define process validation programs
- Provide oversight via review and approval of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
- Support the development of process characterization and process control strategies in accordance with and manufacturing requirements.
- Work cross-functionally with Development, Technical Operations and Quality groups to tech transfer and onboard new clinical manufacturing processes into GMP
- Author and execute qualification and validation protocols, working in conjunction with the Technical Operation and Quality groups
- Act as Process Engineering lead for Deviations, Root Cause Analysis, and CAPAs
- Author and execute Life Cycle Management process activities, and define/coordinate the related Change Control Activities
- Assist in the integration and implementation of digital data enterprises, including electronic Batch Record and data systems
- Contribute to and review regulatory documents
- Train operators and act as Manufacturing Process Engineering super user. Provide guidance and mentor junior scientists
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's degree in life science-related or Engineering discipline with 10 years, Master's degree with 7 yrs. or Ph.D. with 5 years of experience in biotech or life sciences
- Must have at least 5 years of industry experience in Cell Therapy development and manufacturing, including at least 5 years hands-on experience with GMP requirements, quality assurance and Process development.
- Must be familiar with Process method qualification/validation requirements, as well as with GMP Change Control requirements.
- Must be proficient at utilizing statistical analysis tools (JMP or similar) to drive experimental design and optimization via DoE and similar approaches
- 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.
Knowledge and Skills:
- Teamwork Ability to work well in a fast-paced multi-disciplinary environment
- Communication - Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
- Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
- Organization Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
- Motivated Self-motivated and willing to accept temporary responsibilities outside of initial job description
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
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