Astellas Pharma Research Associate II, Analytical Development in Westborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Astellas is announcing a Research Associate II, Analytical Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
The Research Associate II, Analytical development will work on innovative cell therapies. The ideal candidate will assist in analytical method development and optimization of release and characterization assays, analytical method and technology transfer, and analytical method life cycle management. The successful candidate will also assist in planning and executing laboratory studies, analyze experimental data and detailed document resultant information.
Essential Job Responsibilities:
Uses established techniques to work with mammalian cell cultures and generation of mammalian cell banks, and characterize the generated cell banks using molecular biology, biochemistry, and/or immunological assays.
Executes method development and optimization assays, and analyze data in an accurate and reproducible manner
Contributes to assay development design / optimization / validation, and participate the assay development strategy discussion with the supervisor
Provides user training on instruments, sample analysis, and cross-train analysts on analytical methods as needed.
Writes reports detailing procedures, outcomes, and observations.
Maintains accurate record in laboratory notebooks / inventory of reagents and consumables in appropriate databases in a timely manner.
Follows SOPs and/or batch records to execute GxP methods on a regular basis or as needed, in support of process development and product characterization.
BS degree with 3+ years, MS with 0-3 years of laboratory experience
Ability to execute cell-based assays, molecular and/or immunological assays, including but not limited to co-culture, qPCR, ELISA, and/or flow cytometry
Excellent record keeping / communication skills / computer skills including experience with FlowJo, Microsoft Excel, PowerPoint, and Graphpad Prism
Experience of GDP/GLP record keeping, analyze collected data, and write concise reports
Hands-on knowledge of molecular and cell biology analytical method development
Must be able to work flexible hours, including weekends
S./B.S. in cell biology, immunology, molecular biology or related discipline with 3-5 years of relevant academic or industry experience working with mammalian cell cultures
Previous experience with pluripotent stem cells, working knowledge of multi-color flow cytometry, ddPCR, Luminex/MSD experience is preferred
Previous GMP/GTP experience
Knowledge of automated methods for cell analysis
Experience with assay qualification/validation and/or cell therapy products
Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance.
Category Research and Development
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