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Associate Manager (Virus Vector)

Company: Yoh Services LLC
Location: Pleasanton
Posted on: September 19, 2022

Job Description:

Yoh has an exciting opportunity for a Senior Manager, Process Development - Virus Vector to support our rapidly growing Client in Pleasanton, CA specifically in the process development.

The Sr. Manager, Process Development/ Engineering will support process development and engineering efforts within the company for drug substance manufacturing processes. Processes will be focused on chimpanzee adenovirus particles based vaccines for application in oncology and infectious diseases.

This individual will have substantial input toward equipment and technologies assessment and integration, automation, and closed-system evaluation and proposals. As such, this position will be involved in providing technical input for timely patent filings and prosecutions.

Title: Senior Director (Virus Vector)

Salary: Competitive, Depending on experience

Location: Pleasanton, CA

Type: Direct Hire

Job Duties:

  • Design and perform purification process development studies and develop model for process scale-up
  • Lead and mentor team for development and optimization activities
  • Participate in technology transfer activities for transfer to internal manufacturing team as well as external CMO
  • Continually seek and evaluate new potential technologies for rapid production and purification of adeno virus particles
  • Collaborate with formulation scientists to incorporate new/modified formulations in the purification process
  • Lead process improvements toward closed-system, commercial compliant processes, and reduced COGs
  • Support automation lead with process know-how and purification equipment
  • Support process engineering efforts including lean analysis, process device design, creation, and implementation
  • Lead FMEA and RCA efforts
  • Lead Tracking and Trending program structure and reporting
  • Implement T&T application to support process optimization and in process testing guidance
  • Assist Development with sampling plan creation, logistics and use
  • Coordinate and write technical reports on key development findings
  • Support Regulatory Affairs to prepare, file and maintain appropriate regulatory body documents
  • Assist in generation of timetables and budgets for development activities
  • As necessary, support company legal representatives to file and prosecute Company intellectual property
    Minimum Education & Experience
    • PhD in Chemical or Bio-Engineering and 2+ years of experience in pharmaceutical or biotechnology companies OR, B.S./M.S. in Chemical Engineering with 8+ years of experience in pharmaceutical or biotechnology companies
    • 2+ years of experience in people management
    • Expertise in virus and/or other biological product purification required
    • Experience in vaccines or biologics development, production, and CMC regulatory knowledge required
    • Automation experience with lab equipment highly desired
      Other Qualifications
      • Strong organizational skills and attention to detail
        • Able to work effectively in a fast-paced, small start-up company
        • Self-motivated, self-disciplined, and able to function independently as well as part of a team
        • Strategic agility, strong critical and logical thinking with ability to analyze problems
        • Strong ability to prioritize, multi-task, and work in an evolving environment
        • Excellent presentation and written/verbal communication
        • Excellent computer proficiency (MS Word, Excel, PowerPoint)
        • Proficiency using JMP DOE and Statistical software, or equivalent required
        • Up to 15% travel required

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Keywords: Yoh Services LLC, Pleasanton , Associate Manager (Virus Vector), Executive , Pleasanton, California

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