Sr. Scientist

Overview

Axle is looking to add a driven, flexible, organized, and meticulous Sr. Scientist to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Production Program (VPP), Cell Culture Development (CCD).

Technical Requirements:

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  Conduct upstream process development and tech transfer of production processes toward clinical manufacturing of VRC vaccine and antibody clinical candidates within the Cell Culture Development group at the VPP

  
  


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  Provide subject matter expertise to lead scientists and/or associates to develop upstream process methods that meet the productivity and product quality characteristics to achieve successful production of clinical material. Including:

  
  
  
  
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    Designing optimization studies (e.g. DOE with JMP) o Use of high-throughput automated AMBR15 and AMBR250 bioreactors

    
    
  
  
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    Use of fed-batch bench scale bioreactors and scalable Single-Use-Bioreactors SUBs at 50 L (supporting 250 L, 1000 L, and 2000 L manufacturing vessels)

    
    
  
  
  
  


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  Develop pDNA production platform using microbial cell cultures in both shake flask and controller-programmed stirred-tank bioreactor formats.

  
  


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  Collaborate with Project Managers to ensure upstream development milestones are appropriately set and met on time.

  
  


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  Serve as a subject matter expert (SME) in guiding cell culture strategies (media/feed evaluation, control parameter tuning, etc.) for new vaccine or therapeutic mAb candidates (both mammalian and microbial cultures).

  
  


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  Responsible for process evaluation/finalization and oversight of process-locked scale up runs to generate material for toxicology studies. Including, editing/approving/execution of process protocols and production reports.

  
  


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  Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing of the following:

  
  
  
  
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    Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams)

    
    
  
  
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    Serve as Person in Plant or assign designee for initial VCMP production runs.

    
    
  
  
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    Serve as SME in VCMP upstream troubleshooting and facility fit evaluations.

    
    
  
  
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    Serve as the VRC upstream SME in external collaborations.

    
    
  
  
  
  


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  Generate necessary regulatory docs to enable IND submissions, FDA response, etc.

  
  


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  Optimize lab operational space, in collaboration with Process Team Operations Manager and VPP Scientific Operations group, to implement and sustain an optimal productive lab environment (e.g. 5S organizational efforts, KANBAN, or other structural initiatives).

  
  


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  Encourage and drive innovation to meet new upstream challenges and seeks to publicly distribute novel technologies through presentations at national conferences and/or publication in peer-reviewed journals. 

  
  

Specific Qualifications:

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  PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.

  
  


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  Minimum of eight (8) years of experience microbiology and/or cell culture research and development.

  
  


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  Demonstrated knowledge of maintaining accurate and detailed records.

  
  


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  Must be a team player who can effectively work with members from cross-functional departments.

  
  


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  Strong oral and written communication skills.

  
  


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  Familiarity with computer software including word processing and data evaluation.

  
  


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  All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.

  
  


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  The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract.