Engineer IV/Staff Engineer, Process Development応募後で応募 求人ID R0066937 掲載日 05/10/2022 Location:Boston, Massachusetts
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Engineer IV/Staff Engineer, Process Development where you will be part of a small cross-functional team responsible for performing upstream development of viral vector processes. As part of the Process Development team, you will report to Associate Director, Process Development Viral Vector.
How you will contribute:
Design and execute upstream process development studies including seed train development (both adherent and suspension), medium screening, scale-down model development and qualification, and process characterization in flasks and benchtop-scale bioreactors.
Provide technical expertise on cell culture topics such as adherent vs suspension growth, chemically defined media optimization, perfusion systems, feeding strategies, and scale up.
Build in-depth process understanding to support the development of the process control strategy and technology transfer to enable internal or external manufacturing at pilot, clinical, or commercial scales to support Takeda's gene and cell therapy portfolio.
Manage projects within the team to ensure milestones and timelines are met. Present findings and results to senior management, external stakeholders, and industry peers at conferences.
Author and review technical documents, including ELNs, upstream process description, technical reports, batch records, SOPs, and contributes to regulatory submissions and query responses.
Bachelor's degree in chemistry, biology, engineering, or related pharmaceutical science; 5+ years relevant industry experience.
Master's degree in chemistry, biology, engineering, or related pharmaceutical science; 3+ years relevant industry experience.
Previous Process Development, Manufacturing Sciences, or Manufacturing hands-on experience working with suspension cell culture such as shake flasks, ambr15/250 and bioreactors/fermenters, including process monitoring and process control is required.
Experience with cell banking, inoculum/seed train processes, scale-up/scale-down is required.
Prior experience with tech. transfer, QbD principals to process development and process characterization is a plus.
Experience working with viral vectors such as AAV and Lentivirus is preferred.
Experience in statistical design of experiments (DoE) coupled with analytical and problem-solving skills to solve problems creatively and help improve product and process development.
Excellent verbal and written communication skills, ability to present at internal and external meetings publication-quality documentation
May require approximately up to 5% travel.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.