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Director, Assay Development
Director, Assay DevelopmentWerfen • Norcross, Georgia, USA
Director, Assay Development

Director, Assay Development

Werfen • Norcross, Georgia, USA
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Overview

Job Summary

Responsible for the strategic planning for the assay development and product development teams to align with corporate objectives. This position will lead the discovery design development and optimization of diagnostic products and assays for our IVD product portfolio. This role will oversee teams to drive innovation in transfusion diagnostics to meet clinical needs and regulatory requirements.

Responsibilities

Key Accountabilities

Leadership & Strategy

  • Lead the assay and product development teams providing scientific and technical guidance.
  • Create a culture of design control princples focused on developing state of the art products with the highest degree of quality
  • Develop and execute strategic plans for assay and product development aligned with company goals.
  • Collaborate with executive leadership to define product development roadmaps.

Assay and Product Development

  • Oversee the discovery design optimization and feasibility of serological molecular immunohematology products and assays.
  • Ensure robustness reproducibility and scalability of assays for clinical and commercial use.
  • Evaluate and implement new technologies and platforms to enhance assay performance to meet clinical needs.

    • Project Management

  • Develop and execute project plans ensuring adherence to timelines budegtary constrints and regualtory requirments.
  • Foster a culutre of innovation within the assay development team

    • Regulatory & Quality Compliance

  • Establish and maintain robust design processes to ensure the reliability and accuracy of diagnostic assays.
  • Collaborate with regulatory affaris to ensure compliance with relevant industry standards and regulations.

    • Team Development

  • Mentor and develop scientific staff on design of experiements and data analysis fostering a culture of innovation and excellence.
  • Focus on potential patent and publication opportunities for the team
  • Recruit and retain top talent in assay development and related disciplines.
  • Performs other duties and responsibilities as assigned

    • Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

    Networking / Key relationships

    Key crossfunctional relationships with other R&D teams Manufacturing Marketing Regulatory and Quality.

    Qualifications

    Minimum Knowledge & Experience required for the position :

  • Ph.D. or Masters degree in Biochemistry Molecular Biology Immunology or related field.
  • Minimum of 10 years of experience in assay and product development within the IVD or life sciences industry.
  • Proven leadership experience managing scientific teams and complex projects.
  • Deep understanding of assay technologies (e.g. ELISA PCR NGS etc).
  • Strong knowledge of regulatory requirements for IVD products.
  • Excellent communication organizational and problem-solving skills.

    • Management has the discretion of substituting relevant work experience for a degree and / or making exceptions to the years of experience requirement.

    Skills & Capabilities :

  • Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation
  • Effective collaborator across departments and with cross- functional teams
  • Demonstrates ability to priortize and manage multple workloads efficiently
  • Intermediate proficiency in Microsoft Office (Word Excel) and specialized systems (TrackWise MasterControl SharePoint).
  • Receptive to feedback and direction; works cooperatively with managers and peers
  • Proven ability to work independently and as part of a team.
  • Organized and detail-oriented with strong problem-solving skills.
  • Committed to continuous improvement and operational excellence
  • Maintain records and files of work and revisions according to procedures and processes by following cGDP.

    • Travel requirements :

    Minimal only as needed for meetings and conferences (5%).

    Required Experience :

    Director

    Key Skills

    Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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    Director Development • Norcross, Georgia, USA

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