Process Development Scientist/Process Engineer

  • Location:Cambridge,MA
  • Department:CMC
  • Type:Full Time
  • Min. Experience:Entry Level

RESPONSIBILITIES:

  • Supply support for the interaction with external manufacturing and development contract manufacturing partners.
  • Supervise technical transfer between development and manufacturing organizations.
  • Provide upstream, downstream, and/or analytical process oversight for manufacturing operations.
  • Communicate process results via internal presentations and formal process development reports.
  • Manage co-ops/interns and internal process development efforts for existing and upcoming programs.
  • Manage CMC lab operations (e.g. instrument service contracts, lab supplies, reagents, etc.).
  • Provide CMC representation on cross-functional project team(s) for clinical and/or pre-clinical program(s).

EDUCATION AND EXPERIENCE: 

  • BS (4+ years of experience); MS (2+ years of experience) or PhD 0-2+ years of experience) in a related life science field.
  • Familiarity with large-scale manufacturing of protein therapeutics and technology transfer activities. The ability to work within a quality system is preferred.
  • Strong problem-solving and troubleshooting skills.
  • Ability to interact on multiple projects at various stages of development.
  • Works well in a highly cross-functional team environment across the Research and Development groups.
  • Some hands-on experience with standard analytical instrumentation (e.g. HPLC, CE, etc.) preferred.
  • Ability to semi-independently formulate and execute an experimental study design to support ongoing process development work and/or investigations.