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Technical Services Senior Specialist

Company: Cameron Craig Group
Location: Oceanside
Posted on: July 15, 2019

Job Description:


Technical Services Senior Specialist----
--
biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells.-- Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.--
--
Team:
establishing a technical services team dedicated to starting up and supporting operations of a viral vector plant. The team is on a rapid growth trajectory.-- This group will work on New Product Introduction (NPI), deviation investigation structure and ownership, CAPA implementation, and electronic batch record (EBR) implementation by bringing in multifunctional industry experience.
--
Responsibilities (including but are not limited to):


  • Lead Tech Transfer of Pipeline products into Clinical/Commercial Manufacturing from Process Development representing manufacturing
  • Support Tech Transfer for other stages of product lifecycle, such as Research or commercial manufacturing
  • Lead project planning and utilize project management methodologies
  • Use experience to provide resolution for technical challenges that may be encountered during Tech Transfer
  • Lead cross-functional Tech Transfer teams, track project status, provide routine updates to leadership and perform risk identification and mitigation
  • As part of Tech Transfer some travel may be required
  • Implement Operational Excellence, Continuous Improvement and Lean manufacturing as core practices
  • Assists in transfer of new technology into manufacturing from Process Development
  • Supports technical transfer of test methods
  • Investigate complex process and operational deviations to provide effective and sustainable solutions
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Assesses feasibility of new or improved processes and conducts critical review of data/trends
  • Evaluates use of alternate Raw Materials
  • Supports QC on technical problems
  • Implements current GMP and all other regulatory specifications as required
  • Establish regulatory and SOP requirements
  • Anticipates and prevents potential issues with regulators
  • Provides guidance and technical advice
  • Escalates potential quality issues to management

    --
    Candidate Qualifications:

    • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
    • Thorough knowledge cell culture or cell therapy manufacturing technical support
    • Cell culture and aseptic processing experience
    • Experience in Project Management and Project Management Methodology
    • Experience leading tech transfers
    • Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
    • Excellent presentation and communication skills with ability to clearly communicate to leadership or regulatory representatives
    • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
    • Must be able to function and contribute as part of a team and contribute to team based decisions
    • Ability to think critically, analytically and have demonstrated troubleshooting and problem solving skills based on deductive reasoning
    • Ability to function efficiently and independently in a dynamic environment
    • Demonstrates excellent written skills (especially technical writing)
    • Self-motivated and willing to accept temporary responsibilities outside of initial job description
    • Well-developed computer skills and fluent with Microsoft office applications
    • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
    • Core Values: Has high integrity, is inclusive of diverse backgrounds, is a team player, strives for excellence, is accountable

      --
      Preferred Qualifications:

      • Thorough knowledge viral vector manufacturing technical support

        --
        Specific education/experience duration requirements:

        • Bachelor's science degree with 10+ years of experience or Master's of Science Degree with 8+ years experience in Cell Therapy, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or Biotechnology

          --
          --

Keywords: Cameron Craig Group, San Diego , Technical Services Senior Specialist, IT / Software / Systems , Oceanside, California

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