MSAT Sr Process Engineer - Drug Product Development

Sana Biotechnology Inc•Cambridge, MA

33d

About The Position

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As MSAT Sr. Process Engineer focused on Drug Product (DP) Development, you will report to the Executive Director of Process Development / MSAT and support unit operations associated with drug product fill/finish, shipping, and point-of-use manipulations for Sana's stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead the development of the DP container, fill operations, secondary packaging, shipping under temperature-controlled conditions, and pre-implantation preparation at the clinical site. As a member of the MSAT team, you will support technology transfers to the manufacturing site. You will travel to the manufacturing site to train the manufacturing team on fill and shipping operations.

Requirements

and/or MS in Chemical, Biological, or Biomedical Engineering plus 7 yrs or equivalent combination of education and work experience
>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

Nice To Haves

Knowledge of PSC and pancreatic islet biology
Experience with DP cell therapy manufacturing processes supporting phase 1 clinical trials
Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
Working knowledge of statistical design of experiments (DoE) and RCA.
Advanced understanding of single use technologies applicable to cell therapy (extractables & leachables, particulate control)
Operating knowledge of controlled-rate freezers, and other cell therapy equipment
Experience developing scale down models
Excellent technical writing skills, including drafting IND sections
Familiar with R, Python, JMP and FlowJo software.

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

Benefits

ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave)
short- and long-term disability
employer paid basic life insurance
additional voluntary life insurance protection
financial wellness programs including financial planning resources
a 401(k) Plan with an immediately vested employer match
Tuition Reimbursement and Student Loan Repayment
Employee Stock Purchase Plan
commuter subsidy
a variety of wellness offerings to support each person individually