Senior Engineer, Downstream Process Development

---

Job description

About the role

Sana Biotechnology has an exciting opportunity for a Downstream Process Development Sr. Engineer. The Sr. Engineer will focus on the development and optimization of downstream manufacturing processes to support production of novel therapeutic viral vectors. You will lead downstream development, process characterization/validation and technical transfer to GMP manufacturing in order to advance Sana's gene therapy pipeline from first-in-human through commercialization. You will also work with internal and external collaborators to design novel and disruptive process platforms to enable process intensification for commercial GMP supply. This role is expected to closely collaborate with multiple teams across Research, Process Development, Analytical Development and Manufacturing and will report to the Executive Director, Head of Purification Process Development.

What you'll do

• Design, optimize and implement small scale purification processes for viruses produced by cell culture
• Optimize downstream unit operations to maximize yield and quality attributes, including batch and/or continuous centrifugation, normal flow filtration, ultracentrifugation, chromatography, and tangential flow filtration
• Lead coordination of downstream development efforts in collaboration with upstream cell culture, analytical development and manufacturing sciences groups including participating in the design of Sana's internal GMP facilities
• Spearhead and lead technology development efforts for disruptive technologies for recovery and purification of novel therapeutic viruses including utilization of internal resources/expertise and external vendor collaborations
• Develop and implement high-throughput approaches for process optimization and characterization that leverage automation, integrated/on-line analytics, and data analysis including DOE methodology and advanced data visualization techniques
• Characterize process robustness, product (cell / virus) quality and process related impurities using in-process /on-line analytical techniques, in addition to off-line measurements
• Apply strong command of bioprocess engineering principles for process scale-up / scale-down, particularly for downstream purification processes intended for GLP tox and GMP production
• Lead and support technology transfer of processes into GMP clinical and commercial manufacturing

What we're looking for

• PhD in Chemical Engineering (or equivalent) with 1-3 years of experience in industry. BA or MS plus 6+ years or equivalent combination of education and work experience
• Demonstrated leadership for effective project management and supervisory aptitude / experience to enable potential expansion of responsibility to include direct reports
• Ability to design, execute, and analyze complex experiments including demonstrated experience in utilizing DOE software and methodology for process development
• Experience working with automated technologies for downstream process development, for example GE AKTA small scale systems and Tecan/Hamilton automated liquid handlers
• Familiarity with risk-based approaches to process development, validation and continuous improvement
• Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail
• Excellent communication and interpersonal skills to work in a cross-functional team environment

What will separate you from the crowd

• Process development experience with large molecules, live viruses, or gene therapies; for example: monoclonal antibodies, adenovirus, adeno-associated virus (AAV), lentivirus, or viral vaccines
• Participation in professional organizations with emphasis on upstream / downstream bioprocessing; including cell culture, purification, viral vector, and cell / gene therapy
• Familiarity with GMP principles and regulations as demonstrated by technology transfer to GMP manufacturing, GMP clinical manufacturing, or significant laboratory support of IND/BLA submissions
• Experience in development and optimization of product-specific or platform affinity chromatography steps for large molecules or viral vectors

What you should know

• Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19

How we work together

• 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 diverse workforce 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 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

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, 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.