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Viral Safety Specialist

2 months ago

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

Position Summary:
Medvacon Life Sciences is looking for 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. Responsibilities include designing viral clearance assessments, developing study protocols, and preparing final documentation to support our Biologics License Application (BLA) submissions.


Key Responsibilities:
  • Designing Viral Clearance Assessments:
    • Craft and implement effective viral clearance strategies to ensure the safety of cell and gene therapy products.
    • Identify potential viral threats and assess their implications.
    • Recommend suitable viral inactivation and removal techniques.
  • Protocol Formulation:
    • Create comprehensive study protocols detailing 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 industry standards.
    • 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 established protocols and timelines.
    • Coordinate with external laboratories and service providers for the execution of viral clearance tests.
    • Monitor study progress and address any challenges that arise during the assessments.
  • Data Interpretation and Reporting:
    • Evaluate study data and interpret findings to assess the effectiveness of viral clearance methods.
    • Compile detailed final reports summarizing study outcomes, including thorough descriptions of methodologies, results, and conclusions.
    • Ensure reports are meticulously documented and appropriate for inclusion in BLA submissions.
  • Regulatory Guidance:
    • Provide expert advice and assistance for regulatory submissions pertaining to viral safety.
    • Address regulatory inquiries and supply additional data or clarifications as necessary.
    • Remain informed on regulatory guidelines 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:
    • At least 5 years of experience in viral clearance assessments within the biopharmaceutical sector.
    • Comprehensive understanding of viral safety standards for cell and gene therapy products.
    • Demonstrated experience in drafting study protocols and preparing technical reports for regulatory submissions.
  • Skills:
    • Strong knowledge of viral inactivation and removal methodologies.
    • Exceptional technical writing and documentation capabilities.
    • Ability to analyze complex datasets 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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