Duration: 2 months with high chance of extension
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.
- Working on DOE (Design of Experiment) and working with New Equipment.
- Taking companies process and putting it into unit operation.
- 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