Director/Bioanalytical Development

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Location
MA
Job Type
Direct Hire
Date
Aug 03, 2018
Job ID
2616028
Director, Bioanalytical and Biomarker Development

my client company, a very dynamic and growing biotech organization is  seeking an experienced and highly technical scientist to join their Bioanalytical/Biomarker team. This strong leader will develop and put into place bioanalytical and biomarker strategies with a robust pipeline with programs that are in early through mid-stage. Some of these will be nucleic acid based.  This is the perfect position for an individual with a strong background in analytical chemistry and/or nucleic acid chemistry, biochemistry or related field who flourishes in a team-oriented, fast-paced, and cross-disciplinary biotech environment. 


POSITION RESPONSIBILITIES:
  • You will lead, supervise and mentor a group of passionate scientists, employing new and traditional LC-MS/MS, immunoassays and molecular technologies to develop assays, qualify or transfer methods to CROs to validate and support preclinical and clinical studies.
  • Responsible for managing the Biomarker/ Bioanalytical team, overseeing the development & implementation of immunoassays, molecular and other biomarker assays in support of multiple therapeutic area programs.
  • Work with CRO laboratories to develop/transfer, validate, and support assay implementation. Knowledge and understanding of GLP guidelines are imperative.
  • He/she will be a strategic and scientific representative for project teams.
  • Create bioanalytical and biomarker strategies as applicable for the development stage.
  • Author and review technical reports, documents related to bioanalytical work, appropriate sections of clinical protocols, global regulatory filing documents, scientific abstracts, publications and presentations.
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  • QUALIFICATIONS:
  • Strong understanding of drug discovery & DEVELOPMENT, spanning all stages of preclinical and clinical development.
  • Experience in Bioanalytical practices, GLP and GCLP guidelines/practices. Management experience required.
  • Ability to manage multiple projects simultaneously.
  • Proven scientific and strategic leadership of cross-functional teams, management of people and innovative projects.
  • Strong communication skills are a must. 
  • Demonstrated ability to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress programs/projects.
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  • EDUCATION/EXPERIENCE:
  • Ph.D. with 10-15 years of experience in the development and application of bioanalytical & biomarker assays (LC-MS, immunoassay platforms and molecular assays) for preclinical and clinical drug development required.
Please get in touch with Joellen Lane: 978-535-9923; joellen@fpccambridge.com for more detailed information.