Remote: Senior Level Cell Therapy Process Engineer (226579)

Life Sciences & Technology | Clinical Research & Clinical Affairs

Location: Remote

Duration: 2 months with high chance of extension

Job Description: 

A Black Diamond client is looking for a Senior Level Cell Therapy Process Engineer with 10-15 years of experience to help them figure out what needs to be done after they had a gap assessment which uncovered 3 gaps in their process. Their process is mostly manual, and they will be looking for this person to tell them what to focus on first, and what can wait 1-2 years. They are pushing towards a BLA in a couple years but they do things proactively and would like a process engineer that understands that and appreciates their desire to fix the issues now as opposed to waiting, they want to ensure their first product gets to commercialization successfully.

Responsibilities:

  • Working on DOE (Design of Experiment) and working with New Equipment.
  • Taking companies process and putting it into unit operation.

Requirements:

  • MUST have significant QBD (Quality by Design) experience, specifically Designing a QBD Program in their past experiences.
  • Experience taking a process from preclinical to BLA.
  • Know how to identify CQA (Critical Quality Attributes), and CPP (Critical Process Parameters).
  • Background in Cell Therapy would be most desirable, next would be background with any protein biologic (like monoclonal antibodies).
  • Experience in managing a team working at bench, so they understand what it takes to design a protocol.
  • Someone who knows what it takes to prove something is true.
  • Must be comfortable coaching junior engineers.

 

JOB ID # 226579

#LI-MV1

Start Date
ASAP
Location
Remote

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