Medvacon Life Sciences
Viral Clearance Expert
Medvacon Life Sciences, Sparta, New Jersey, us, 07871
Position Summary:We are seeking a highly skilled Viral Clearance Expert to join our consulting team. The successful candidate will play a crucial role in ensuring the viral safety of our cell and gene therapy products. This individual will be responsible for formulating viral clearance studies, drafting study protocols, and writing final reports to support our Biologics License Application (BLA) submissions.
Key Responsibilities:
Formulation of Viral Clearance Studies:
Design and develop robust viral clearance strategies to ensure the safety of cell and gene therapy products.Identify potential viral contaminants and evaluate their risks.Select and recommend appropriate viral inactivation and removal methods.
Protocol Development:
Draft detailed study protocols outlining the objectives, methodology, and acceptance criteria for viral clearance studies.Collaborate with cross-functional teams including process development, quality control, and regulatory affairs to ensure protocols meet regulatory requirements and industry standards.Ensure protocols are aligned with current Good Manufacturing Practices (cGMP) and ICH guidelines.
Study Execution and Oversight:
Oversee the execution of viral clearance studies, ensuring adherence to protocols and timelines.Coordinate with external laboratories and vendors for the execution of viral clearance assays.Monitor study progress and troubleshoot any issues that arise during the studies.
Data Analysis and Reporting:
Analyze study data and interpret results to determine the efficacy of viral clearance methods.Prepare comprehensive final reports summarizing study findings, including detailed descriptions of the methods, results, and conclusions.Ensure reports are well-documented and suitable for inclusion in BLA submissions.
Regulatory Support:
Provide expert input and support for regulatory submissions related to viral safety.Respond to regulatory inquiries and provide additional data or clarification as needed.Stay updated on regulatory guidelines and industry best practices related to viral safety in cell and gene therapy.
Qualifications:
Education:
Ph.D. or Master's degree in Virology, Microbiology, Biochemistry, Biotechnology, or a related field.
Experience:
Minimum of 5 years of experience in viral clearance studies within the biopharmaceutical industry.In-depth knowledge of viral safety requirements for cell and gene therapy products.Proven track record of drafting study protocols and writing technical reports for regulatory submissions.
Skills:
Strong understanding of viral inactivation and removal techniques.Excellent technical writing and documentation skills.Ability to analyze complex data and present clear, concise findings.Strong project management and organizational skills.Ability to work effectively in a team-oriented environment.
Other:
Familiarity with cGMP, ICH guidelines, and regulatory requirements for viral safety.Excellent communication and interpersonal skills.Attention to detail and a high level of accuracy.
This is a remote contract position with no benefits.
Key Responsibilities:
Formulation of Viral Clearance Studies:
Design and develop robust viral clearance strategies to ensure the safety of cell and gene therapy products.Identify potential viral contaminants and evaluate their risks.Select and recommend appropriate viral inactivation and removal methods.
Protocol Development:
Draft detailed study protocols outlining the objectives, methodology, and acceptance criteria for viral clearance studies.Collaborate with cross-functional teams including process development, quality control, and regulatory affairs to ensure protocols meet regulatory requirements and industry standards.Ensure protocols are aligned with current Good Manufacturing Practices (cGMP) and ICH guidelines.
Study Execution and Oversight:
Oversee the execution of viral clearance studies, ensuring adherence to protocols and timelines.Coordinate with external laboratories and vendors for the execution of viral clearance assays.Monitor study progress and troubleshoot any issues that arise during the studies.
Data Analysis and Reporting:
Analyze study data and interpret results to determine the efficacy of viral clearance methods.Prepare comprehensive final reports summarizing study findings, including detailed descriptions of the methods, results, and conclusions.Ensure reports are well-documented and suitable for inclusion in BLA submissions.
Regulatory Support:
Provide expert input and support for regulatory submissions related to viral safety.Respond to regulatory inquiries and provide additional data or clarification as needed.Stay updated on regulatory guidelines and industry best practices related to viral safety in cell and gene therapy.
Qualifications:
Education:
Ph.D. or Master's degree in Virology, Microbiology, Biochemistry, Biotechnology, or a related field.
Experience:
Minimum of 5 years of experience in viral clearance studies within the biopharmaceutical industry.In-depth knowledge of viral safety requirements for cell and gene therapy products.Proven track record of drafting study protocols and writing technical reports for regulatory submissions.
Skills:
Strong understanding of viral inactivation and removal techniques.Excellent technical writing and documentation skills.Ability to analyze complex data and present clear, concise findings.Strong project management and organizational skills.Ability to work effectively in a team-oriented environment.
Other:
Familiarity with cGMP, ICH guidelines, and regulatory requirements for viral safety.Excellent communication and interpersonal skills.Attention to detail and a high level of accuracy.
This is a remote contract position with no benefits.