Immunogenicity Research Scientist \/ Manager

Woburn, Massachusetts

The Immunogenicity Research Scientist/Manager will work as part of a team in a laboratory environment to complete client/Sponsor driven projects. Scientist will be responsible to develop and validated GxP immunogenicity assays for Biologics and CGT. This is a remote role with 20% travel required.

Primary responsibilities include:

  • Performing Scientific Review for project reports in area of expertise.
  • Serving as a team leader and/or Principal Investigator (PI) and leading the technical, scientific, budgetary, and regulatory aspects of development and validation of cellular and humoral immunogenicity assays including GxP studies.
  • May have up to five direct reports and working as a group leader and/or Senior Manager.
  • Demonstrating broad knowledge in the related technical area and functioning as a subject matter expert and technical leader both within and outside of the department.
  • Write SOPs, validation protocols, and reports
  • Overseeing project timelines and putting best efforts into increasing productivity.
  • Representing the company in scientific conferences or participating in sales meetings as required.
  • Working with management and QAU to maintain and improve quality systems.
  • Authoring and reviewing Protocols, Reports, Deviations, and Audit responses.
  • Providing leadership, mentoring, and training to assigned scientific staff.
  • Performing a QC function to review data and reports to ensure the accuracy of all laboratory-related processes.
  • Maintaining regular communication with QAU, scientists, PIs, and other project staff and becoming the client's technical point of contact for an assigned project or program.
  • Additional duties and responsibilities as required.

Job Qualifications and Requirements:
  • BS with at least 8 years of relevant experience, MS with at least 5 years of relevant experience, or PhD with at least 2 years of relevant experience.
  • Experience with immunoassays and cell based assay techniques like ELISA, Flow Cytometry, ELISpot, MSD, WB is critical.
  • Experience with validating cellular and humoral immunogenicity assays under GxP regulations including basic statistical analysis is required.
  • Ability to quickly acquire new skills and craft creative solutions.
  • Must be detail oriented with the ability to multi-task and work as part of a team to complete projects.
  • Strong oral and written communication skills and the ability to work without supervision in a team environment. Will participate in client meetings.
  • Excellent computer skills are required. Must be proficient in Microsoft Office including Word, Excel (formulas, graphs and charts), and PowerPoint.

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