MSAT Technical Specialist

MSAT Technical Specialist

9-Month Contract

Hybrid - Cambridge, MA

$50-$60/hr

Weekend rotation required (1-2x/mo.)

2 Open Positions

• 1st - Hybrid, no overnight travel (Boston based)
• 2nd - Hybrid, 75% overnight travel (Boston based)

About our Client: Our client is focused on utilizing engineered cells as medicines for patients. The ability to modify genes and use cells as medicines will be one of the most important advances in healthcare over the next several decades. Our client is building differentiated capabilities across the spectrum of cell and gene therapy.

About the role:

Supporting a growing Biotechnology company as the MSAT Technical Specialist, you will support manufacturing of the stem cell-derived pancreatic islet cell program for persons with type 1 diabetes. In collaboration with the MSAT team, you will provide phase 1 clinical manufacturing support and oversight. You will support technology transfers to the manufacturing site. You will travel to the site to serve as person-in-plant during manufacturing runs.

What you’ll do:

• Apply GMP manufacturing principles to oversee pluripotent stem cell (PSC)-based cell therapy manufacturing
• Support technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Provide onsite manufacturing support at the CDMO, train manufacturing operators, and oversee process execution
• Review executed batch records, collaborate with QA to close process deviations, analyze manufacturing trends, and recommend improvements
• Support investigations to troubleshoot process execution challenges including root cause analysis
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

What we’re looking for:

• Degree in Chemical, Biological, or Biomedical Engineering plus or 3 years of equivalent combination of education and work experience

• 2 years of GMP manufacturing experience in cell therapy with knowledge of cleanroom operations

• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.

What will separate you from the crowd:

• Experience with adherent and suspension PSC culture and cell differentiation processes
• Knowledge of PSC and pancreatic islet biology
• Experience with automated cell wash/harvest instruments
• Experience with cell therapy fill/finish operations
• Working knowledge root cause analysis and deviation management.
• Operating knowledge of bioreactors, controlled-rate freezers, and other cell therapy equipment

What you should know:

• 75% of the time, onsite at CDMO
• Some weekend rotational work required (approximately every 3rd weekend)
• Lift up to 25lbs
• Working within a cleanroom environment