Device Engineer/ Senior Research Associate
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Job Description
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 a Device Engineer/Senior Research Associate where you will support laboratory activities related to the in-use qualification/compatibility testing of biologic/device combination products and stand-alone medical devices being developed within Takeda's pipeline and commercial product portfolios. You will also help identify user needs and the design of verification and validation testing to further assess any impact of our devices on Takeda's drug products. As part of the Drug Device Qualification and Compatibility team, you will report to Principal Scientist/Delivery Systems Qualification and work with a team of scientist within Medical Device Drug Device Qualification and Compatibility group (DDDC) group and other internal medical device drug product development engineering teams.
How you will contribute:Implement feasibility, material compatibility, and in-use qualification testing, and would experience a range of life cycle development activities for Takeda's medical devices including early feasibility studies and commercial investigations.
Implement biological device compatibility studies including method development, qualification and studies designed to support device development including early feasibility studies and late stage commercial investigations.
Author documentation and data analysis.
Wet laboratory bench work for which an analytical/formulation development background is beneficial.
Become proficient in the execution of various device development studies to improve our development pipeline.
These activities include in-use compatibility studies, device pumping studies, aseptic technique, light microscopy, and instrument and test method qualification.
Subvisible particle analysis (SVP), such as Micro-Flow imaging (MFI) and HIAC, is a large part of this role with a need for evaluating and implementing newer SVP characterization technologies including the use of electronic filters.
BA/BS in a relevant scientific discipline or related degree in the pharmaceutical field, with 2+ years of relevant industry and/or lab experience.
Understanding of GMP, GLP, and GXP.
Hands-on laboratory experience. Experience performing visible and sub-visible particle analyses is desirable, but not required.
Flexible with assignments to meet the changing needs of projects, and able to produce and review data promptly is paramount for decision making.
In-depth knowledge of biological macromolecules is preferred.
Understanding of in-use compatibility study design is preferred.
Knowledge of global industry standards (ex: ICH, ISO, AAMI, ANSI) is preferred.
Hands on experience with physical and bioanalytical characterization instrumentation such as viscometer, densitometer, Solo-VPE, HPLC/UPLC (SE, RP, ion exchange), FTIR, and Microflow Imaging Technology (MFI), HIAC, and other particle characterization/identification techniques preferred.
Perform lab work independently and be familiar with the use of standard computer applications (Word, Powerpoint and Excel), and follow good documentation practices including data integrity.
You will work in a goal oriented and timeline driven environment.
You will work in a full time, on-site laboratory position and you will expected to be on-site 80% of the time.
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
Tuition reimbursement
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.
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EEO Statement
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.