MSAT Sr Process Engineer - Drug Product Development

Role Summary

MSAT Sr. Process Engineer focused on Drug Product (DP) Development, reporting to the Executive Director of Process Development / MSAT, supporting unit operations for drug product fill/finish, shipping, and point-of-use manipulations for Sana’s stem cell-derived pancreatic islet cell program. Lead DP container development, fill operations, secondary packaging, temperature-controlled shipping, and pre-implantation preparation at the clinical site. Support technology transfers to the manufacturing site and travel to train the manufacturing team on fill and shipping operations.

Responsibilities

• Lead drug product fill/finish process development, shipping process, support in-use stability studies, and on-site preparation
• Develop and qualify temperature-controlled shipping solutions suitable for cell therapy products
• Work with Supply Chain to ensure successful transfer of DP between manufacturing and clinical sites
• Support technology transfer of fill operations and shipping procedures to the CDMO
• Author technical documents including reports, standard operating procedures, master batch records, work instructions
• Provide onsite support at the CDMO, develop training plan covering fill and shipping operations, and oversee process execution
• Draft pharmacy and administration manual (PAM) sections in collaboration with the clinical team
• Review executed batch records, collaborate with QA to close process deviations, analyze manufacturing trends, and recommend improvements
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Qualifications

• BS and/or MS in Chemical, Biological, or Biomedical Engineering plus 7 yrs or equivalent combination of education and work experience
• Greater than 4 years of experience applicable to cell therapy drug product development
• Experience with GMP fill/finish operations
• Experience validating DP product shipping processes and containers
• Experience supporting technology transfers to an external CDMO, preferably of cell therapy processes
• 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

Skills

• PSC and pancreatic islet biology knowledge
• DP cell therapy manufacturing processes for phase 1 clinical trials
• cGMP requirements and regulated environments; experience as person-in-plan and/or GMP operator
• Statistical design of experiments (DoE) and root cause analysis (RCA)
• Single-use technologies for cell therapy (extractables & leachables, particulate control)
• Controlled-rate freezers and other cell therapy equipment
• Scale-down model development
• Technical writing including drafting IND sections
• Proficiency with R, Python, JMP and FlowJo

Education

• BS and/or MS in Chemical, Biological, or Biomedical Engineering (as listed above)

Additional Requirements

• Travel to the manufacturing site approximately 20% of the time
• Work in a laboratory environment approximately 30% of the time
• Lift up to 25 lbs
• Work within a cleanroom environment