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Astellas Pharma Research Associate II/Senior 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 affiliate Astellas Institute of Regenerative Medicine (AIRM) 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:

  • Growing technical knowledge and continued understanding of administrative operations with ability to troubleshoot and solve technical problems.
  • Independently contributing to the scientific experiments and continues to take on more responsibility to provide content for various documents and reports.
  • Able to execute protocols and have ability to summarize results independently.
  • Utilizes established techniques in cell culture, cell and molecular biology, biochemistry, and immunology to generate data in an accurate and reproducible manner.
  • Conducts experiments after discussion of the design and strategy with the supervisor.
  • Contributes to drug product and its process development.
  • Performs literature searches and analysis as needed for drug product development.
  • Subcultures, freezes and characterizes cells in the drug product using SOPs.
  • Writes technical reports detailing procedures, outcomes, and observations.
  • Follows SOPs and batch records.
  • Maintains accurate record keeping in laboratory notebooks and appropriate databases in a timely manner.
  • Maintains 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 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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Research and Development

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