US-MA, Engineer IV 1701256-MZ
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
Responsible for providing technical leadership for commercial project implementation and coordination by independently planning and transferring unit operations/characterization and optimization efforts. Additionally this position assists with preparing technology transfer documentation and provides onsite support/trouble shooting during technology transfer or manufacturing CMOs as appropriate. This may include leading technology transfer activities and compiling vendor data for presentation. This position also independently interprets and communicates results and owns technical aspects of a project. This FTE will manage and prioritize tasks providing support to Contract Manufacturing, Quality, and Validation for deviation investigation, change controls, and CAPA. In addition , the Engineer will perform originator/author and EMR administration functions in documentation systems (Trackwise and Mosaic). Provide leadership and guidance to cross functional teams associated with change review. Attend and present at CMC,CCRB and MRB investigation meetings as required.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
LINE FUNCTION SPECIFIC QUALIFICATIONS:
Biologics - Cell Culture: Statistical analysis techniques; Experience with cell culture and aseptic techniques; Experience laboratory equipment that supports cell culture, such as bioreactors, metabolite analyzers, shake flasks, cell culture plates; Familiar with large scale cell culture manufacturing; Experience with equipment automation and control.
Biologics - Purification: Solid understanding of chromatographic and other protein separation principles; Hands-on experience with the development and scale-up of purification processes and the use of bioseparation equipment; Knowledge of design of experiments principles and statistical analysis techniques; Experience with standard analytical assays
Biologics ADC: Solid understanding of bioconjugation principles; Experience with common conjugation chemistries; Knowledge of design of experiments principles and statistical analysis techniques; Handling of cytotoxic compounds required; Experience with standard bioconjugation assays
we are driven to improve people's lives
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