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Affinivax Group Lead/Principal Scientist, Analytical Immunology Method Development in Cambridge, Massachusetts

Group Lead/ Principal Scientist, Analytical Immunology Method Development Position

Reports to: Director, Analytical Development

Company Overview

Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next generation approach to the development of vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high affinity binding of protective polysaccharides and proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.

Affinivax is currently seeking a highly motivated and experienced scientist to use his/her expertise in assay development, especially in the ligand-binding-based assay development, to continue to drive various vaccine development programs. The Analytical Development Team at Affinivax is responsible for the development and qualification of assays to support IND-enabling toxicology studies and clinical trials. This position is ideal for someone with extensive experience in ligand-binding method development/qualification and team management.

Key Duties & Responsibilities:

  • Lead, design, develop, qualify, and implement ligand-binding assays to support early and late-stage infectious disease vaccine development programs.

  • Align priorities to the entire program development strategy. Effectively plan and ensure project deliverables and timelines are met.

  • Lead and mentor a sub-team within the AD team, supervise the day-to-day laboratory activities, identify potential issues, and deliver high-quality data within defined timelines.

  • Troubleshoot method and instrumentation problems; be proactive in solving technical issues.

  • Author, review, and approve SOPs, study protocols, reports, and other scientific and quality documents.

  • Present scientific data to colleagues in group meetings and prepare and present internal and external presentations.

    Qualifications & Expertise:

  • Ph.D. (Biochemistry, Immunology, or related discipline) with a minimum of 6 years of post-graduate experience (preferably industry and preferably experience with GxP). Proven experience in project management and team management.

  • Extensive hands-on working experience in ligand-binding method development and qualification. In-depth expertise in Nephelometry, MSD, Luminex, alphaLisa based multiplex immunoassay is a plus.

  • Experience in running stability protocols with associated experimental planning and data collection and analysis.

  • Familiarity with the regulatory landscape and guidance for drug product potency testing.

  • Data processing skills using Windows-based software (Excel, GraphPad Prizm, Jmp, etc.)

  • Able to maintain written records in the form of laboratory notebooks

  • Strong ability to multi-task and willingness to work effectively in a highly collaborative and diverse environment as a team player with a strong work ethic .

  • Ability and desire to work in a fast-paced environment.

  • Excellent oral and written communication skills.

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