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Astellas Pharma Sr. Research Associate, Drug Product 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 Sr. Research Associate, Drug Product Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Sr. Research Associate will support drug product development including formulation screening and process development by performing cell culture and wet lab experiments, analyzing data, and drafting protocols, SOPs and reports. You will be able to independently execute protocols with some guidance and have the ability to summarize results independently. This individual will collaborate closely within the team and across functional groups to advance pipeline programs.

Essential Job Responsibilities:

  • Grow technical knowledge related to cell biology, formulation, and cryopreservation of key cells.
  • Maintenance of mammalian cell culture, including sub-culturing, harvesting, freezing and characterizing cells in the drug product using SOPs.
  • Utilize established techniques in cell culture, cell and molecular biology, biochemistry, and immunology to generate data in an accurate and reproducible manner.
  • Independently contribute to the scientific experiments and continue to take on more responsibility to provide content for various documents and reports.
  • Execute protocols and write technical reports detailing procedures, outcomes, and observations.
  • Apply critical thinking skills to troubleshoot and solve technical problems with the supervisor.
  • Perform literature searches and analysis as needed for drug product development.
  • Maintain accurate record keeping in laboratory notebooks and appropriate databases in a timely manner.
  • Develop new experiments after discussion of the design and strategy with the supervisor.
  • Maintain inventory of reagents and disposables and orders supplies as needed.

Qualifications:

Required

  • BS degree with 5+ years of laboratory experience or MS with 2 years.
  • Ability to work independently, as well as part of a team
  • Self-reliant, self-motivated, detail-oriented, highly organized
  • Willingness and ability to learn new skills
  • Two or more years' experience with aseptic tissue/cell culture technique
  • Hands-on knowledge of cell biology
  • Capable of meticulous GDP (Good Document Practice) record keeping
  • Excellent communication skills
  • Ability to analyze own data and write concise reports
  • Must be able to work flexible hours

Preferred

  • Previous experience with pluripotent cells, working knowledge of flow cytometry, qPCR, ELISA and/or HPLC experience
  • Previous GMP experience
  • Knowledge of drug product development
  • Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance.
  • Flexibility of working in weekends

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Research and Development

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