MSAT Sr Process Engineer - Drug Product Development at Sana Biotechnology

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Feb, 26

Salary

160000.0

Posted On

20 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Cell Therapy, GMP Operations, Technical Writing, Problem-Solving, Temperature-Controlled Shipping, Technology Transfer, Statistical Design, Single Use Technologies, Controlled-Rate Freezers, Training Development, Batch Record Review, Collaboration, Analytical Skills, Attention to Detail, Communication Skills

Industry

Biotechnology Research

Description

About the role 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. What you’ll do 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 What we’re looking for 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 What will separate you from the crowd 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. What you should know Travel to the manufacturing site ~20% of the time Work in a laboratory environment ~30% of the time Lift up to 25 lbs Work within a cleanroom environment The base pay range for this position at commencement of employment is expected to be between $$125,000 - $160,000 annually ; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together for patients Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer 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 and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal. We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

Responsibilities

Lead drug product fill/finish process development and ensure successful transfer of drug product between manufacturing and clinical sites. Author technical documents and provide onsite support at the CDMO while overseeing process execution.