(ID: 2025-0445)

Axle
is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Benefits:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Match
• Tuition reimbursement and professional development opportunities
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Overview

Axle is looking to add a driven, flexible, organized, and meticulous
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) Downstream group, and management of process development processes.

Technical Requirements:

• Oversee
   
  the
   
  development
   
  of
   
  downstream
   
  processes
   
  for
   
  VRC
   
  clinical
   
  candidates
   
  and
   
  the process tech transfer to the VCMP for clinical material generation for the VRC.
• Provide
   
  project
   
  support
   
  to
   
  lead
   
  scientists
   
  and/or
   
  associates
   
  to
   
  develop
   
  downstream
   
  process methods
   
  that
   
  meet
   
  the
   
  product
   
  quality
   
  and
   
  recovery
   
  characteristics
   
  to
   
  guarantee
   
  successful production of clinical material.
• Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle. This includes efforts in designing optimization studies
   
  (DOE
   
  with
   
  JMP)
   
  and
   
  streamlining
   
  efforts
   
  to
   
  ensure
   
  timely
   
  development
   
  schedules.
• Work
   
  closely
   
  with
   
  Project
   
  Managers
   
  to
   
  ensure
   
  downstream
   
  milestones
   
  are
   
  appropriately
   
  set and met on time.
• Serve
   
  as
   
  a
   
  subject
   
  matter
   
  expert
   
  (SME)
   
  in
   
  guiding
   
  purification
   
  strategies
   
  for
   
  new
   
  vaccine
   
  or therapeutic mAb candidates (both internal to the downstream team and throughout the
  VPP).
• Responsible
   
  for
   
  planning
   
  and
   
  overseeing
   
  the
   
  downstream processes
   
  for
   
  toxicology
   
  lot
   
  material production.
   
  This
   
  includes
   
  editing/approving
   
  all
   
  process
   
  protocols,
   
  managing
   
  execution
   
  thereof, and the generation of production reports following successful campaigns.

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

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

   

  to

   

  support

   

  VCMP

   

  downstream

   

  process

   

  Master

   

  Batch

   

  Record

   

  authoring.

  • Serve
     
    as
     
    Person
     
    in
     
    Plant
     
    or
     
    assigns
     
    team
     
    designee
     
    for
     
    initial
     
    VCMP
     
    production
     

    runs.

  • Serve
     
    as
     
    SME
     
    in
     
    VCMP
     
    downstream
     
    troubleshooting
     
    and
     
    facility
     
    fit
     

    calculations.

  • Serve

     

    as

     

    the

     

    VRC

     

    downstream

     

    SME

     

    in

     

    external

     

    collaborations

     

    for

     

    projects

     

    outside

     

    of VCMP-path clinical development

• Work
   
  with
   
  regulatory
   
  team,
   
  as
   
  needed,
   
  to
   
  support
   
  IND
   
  submissions
   
  and
   
  other
   

  requests.

• Oversee
   
  viral
   
  clearance
   
  strategies
   
  in
   
  relevant
   
  downstream
   
  processes
   
  and
   
  directs
   
  the
   
  viral clearance validation efforts (SEG evaluation of CRO vendors, scale-down method SOP/validation approval, etc.

• Encourage
   
  and
   
  drive
   
  innovation
   
  to
   
  meet
   
  new
   
  downstream
   
  challenges
   
  and
   
  seeks
   
  to
   

  publicly 

  distribute
   
  novel
   
  technologies
   
  through
   
  presentations
   
  at
   
  conferences
   
  and/or
   
  publication
   
  in
   
  peer- reviewed journals.

Specific Qualifications:

• PhD
   
  in
   
  Bioengineering,
   
  Chemical
   
  Engineering,
   
  Biochemistry,
   
  or
   
  a
   
  related
   
  discipline
   
  is
   

  required.

• Minimum
   
  of
   
  eight
   
  (8)
   
  years
   
  of
   
  experience
   
  in
   
  recombinant
   
  protein
   
  purification development for GMP clinical-phase products is required.

• Demonstrated
   
  knowledge
   
  of
   
  maintaining
   
  accurate
   
  and
   
  detailed
   

  records.

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

• Strong
   
  oral
   
  and
   
  written
   
  communication
   

  skills.

• Familiarity
   
  with
   
  computer
   
  software
   
  including
   
  word
   
  processing
   
  and
   
  data
   

  evaluation.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com

Disclaimer:
The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

Salary Range: $140,000 USD – $150,000 USD