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Manager/ Sr. Manager, GCP Quality in Cambridge, MA

Agios Pharmaceuticals

Cambridge, MA 02138
5w ago


Quality Management, Life Sciences


5 - 7 years

Job Description

Agios is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.

Agios is seeking a highly motivated Manager/Sr. Manager, GCP Quality. The candidate should be able to conduct audits, provide Quality GCP consultation to clinical teams, lead inspection readiness activities, and provide direction to Agios stakeholders regarding GCP related activities/issues.

Responsibilities Include:

  • Serve as the GCP Quality representative for clinical study teams (CTWGs).
  • Provide ICH/GCP guidance and clinical compliance knowledge to the CTWGs, inclusive of supporting risk iden
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Valid through: 2020-3-5

About Agios Pharmaceuticals

Agios Pharmaceuticals is a public American pharmaceutical company focused on developing small-molecule anti-cancer therapeutics targeting cancer cell metabolism via the growth factor pathway. Among the proteins under investigation by the company are IDH1 and IDH2. The company was founded in 2008 (or 2007) by Lewis Cantley, Tak Mak and Craig Thompson. Agios is a Delaware corporation headquartered in Cambridge, Massachusetts. The company tendered an initial public offering in July 2013.:Table 1 In 2012, Agios was named among the defendants in a lawsuit against one of its founders, Craig Thompson, alleging that Thompson used research illegally taken from the Abramson Family Cancer Research Institute in research at Agios. In May 2016, the company announced it would launch partnership with Celgene, developing metabolic immuno-oncology therapies. The deal could net more than $1 billion for Agios.
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