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Viral Safety Specialist

2 months ago

Sparta, New Jersey, United States Medvacon Life Sciences Full time
Job Overview

Position Summary:
We are in search of a proficient Viral Clearance Specialist to enhance our consulting division. The ideal candidate will be instrumental in safeguarding the viral integrity of our cell and gene therapy offerings. This role encompasses the design of viral clearance assessments, the creation of study protocols, and the preparation of conclusive reports to facilitate our Biologics License Application (BLA) processes.


Key Responsibilities:
  • Development of Viral Clearance Assessments:
    • Craft and implement effective viral clearance methodologies to guarantee the safety of cell and gene therapy products.
    • Detect potential viral threats and assess their implications.
    • Advise on suitable viral inactivation and elimination techniques.
  • Protocol Formulation:
    • Compose comprehensive study protocols that detail objectives, methodologies, and acceptance criteria for viral clearance assessments.
    • Collaborate with interdisciplinary teams, including process development, quality assurance, and regulatory compliance, to ensure protocols adhere to regulatory standards and industry norms.
    • Align protocols with current Good Manufacturing Practices (cGMP) and ICH guidelines.
  • Execution and Management of Studies:
    • Supervise the implementation of viral clearance assessments, ensuring compliance with protocols and timelines.
    • Coordinate with external laboratories and service providers for the execution of viral clearance tests.
    • Track study progress and resolve any challenges encountered during the assessments.
  • Data Interpretation and Reporting:
    • Evaluate study data and derive conclusions regarding the effectiveness of viral clearance strategies.
    • Compile detailed final reports that encapsulate study outcomes, including thorough descriptions of methodologies, results, and interpretations.
    • Ensure reports are meticulously documented and appropriate for inclusion in BLA submissions.
  • Regulatory Assistance:
    • Offer expert guidance and support for regulatory submissions pertaining to viral safety.
    • Address regulatory inquiries and provide supplementary data or clarifications as required.
    • Remain informed on regulatory standards and industry best practices concerning viral safety in cell and gene therapy.
Qualifications:
  • Education:
    • Ph.D. or Master's degree in Virology, Microbiology, Biochemistry, Biotechnology, or a related discipline.
  • Experience:
    • A minimum of 5 years of experience in viral clearance assessments within the biopharmaceutical sector.
    • Extensive knowledge of viral safety protocols for cell and gene therapy products.
    • A proven history of drafting study protocols and preparing technical reports for regulatory submissions.
  • Skills:
    • Deep understanding of viral inactivation and removal processes.
    • Exceptional technical writing and documentation capabilities.
    • Ability to analyze intricate data and present clear, concise findings.
    • Strong project management and organizational abilities.
    • Capability to work effectively in a collaborative environment.
  • Other:
    • Familiarity with cGMP, ICH guidelines, and regulatory standards for viral safety.
    • Outstanding communication and interpersonal skills.
    • Meticulous attention to detail and a high degree of accuracy.

This is a remote contract position with no benefits.

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