Sr. Associate I, QC Reference Standards/Qualified Materials

Job Description

About This Role

Biogen’s QC Reference Standards and Qualified Materials (RSQM) group is responsible for the preparation, qualification, and management of reference standards, controls, critical assay reagents, and cells used in analytical methods for Biologics, Small Molecules, ASO, and Gene Therapy programs. The Sr. Associate I position is responsible for coordinating reference standard and reagent qualification initiatives/projects, ensuring all work adheres to cGMP and regulatory regulations. This role requires technical ability to evaluate qualification results and appropriately document results in a technical report. This role reports into the RSQM manager and is cross-functional with stakeholders in QC and development laboratories, Analytical Technology, Global Stability, Regulatory, and Product Development Quality.

WhatYou’llDo
  • Manage preparation, qualification, and inventory for assigned reference standards or qualified materials
  • Author and review technical qualification protocols, reports, and change control requests to support qualification of reference standards, controls, and assay reagents
  • Coordinate qualification testing, in collaboration with the laboratory operations and Analytical Technology/Development groups
  • Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the QC RSQM group
  • Ship materials to international partners, CLOs, and Ministry of Health laboratories to enable uninterrupted supply of products to patients


Who YouAre

Our ideal candidate is detail oriented, enjoys problem solving, and excels at individual responsibilities within the team environment. This position will provide the opportunity to collaborate and innovate within a group who is passionate about transforming patient lives worldwide.

Qualifications

Required Skills
  • Ph.D 3+ / M.S. 5+ / B.S. 8+ years in comparable role
  • Laboratory experience in Bioassay, Chemistry, and/or Virology
  • Background in one or more biopharma/pharma areas including Biologics, Small Molecules, ASO, or Gene Therapy
  • Knowledge of bioassay and chemical analytical methods including PCR and cell-based assays
  • Understanding of basic statistical applications; i.e., JMP and control trending (experience with parallel line analysis is beneficial)
  • Excels in technical writing, communication, and project management
  • A collaborative work ethic
  • Works independently
  • Customer-focused




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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