Head of Purification Process Development
- Employer
- Sana Biotechnology
- Location
- South San Francisco, CA
- Start date
- Nov 7, 2021
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay, NextGen Bio
Job Details
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 want to challenge status quo, and who lead with the desire to work on novel ideas. As the Head of Purification Process Development, you will report to the Head of Technical Operations and will lead a group of engineers/scientists responsible for developing a strategy for purification process development to support viral vectors and gene editing reagents for clinical and commercial production. You will also define appropriate characterization, validation, tech transfer activities for manufacturing process throughout the product lifecycle.
What you’ll do
- Provide strategic and technical leadership in the development of purification processes used for manufacturing of Sana’s gene and cell therapy pipeline
- Provide strategic and technical leadership in the characterization, validation, tech transfer activities required to ensure successful execution of the processes in manufacturing, including external CDMOs.
- Develop the content of relevant the CMC sections of regulatory dossiers, supporting regulatory queries and inspections
- Champion and drive technical innovations for the continuous improvements of platform technologies, include both internal and external innovation through collaborations with academic research institutions and suppliers
- Build strong collaborations across functions within Sana with research, other process development functions, analytical development, quality and regulatory groups to align activities to rapidly advance Sana’s pipeline
- Build a world class team that will execute on the defined strategy
- As a member of the Tech Ops leadership team, develop the organization strategy, champion the Sana culture and make it a great place to work
- Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
- 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
- Innate ability to assess talent that will help grow the organization and add to Sana’s culture
What we’re looking for
- Knowledge and industry expertise of advanced scientific principles, practices and standards to process and product development in biotechnology field
- Current scientific knowledge and latest technologies in areas of purification processes, including chromatography, filtration, etc
- Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment
- Excellent writing skills including authoring regulatory filings are required
- Ability to deliver results consistently and effectively
- Ability to communicate across all levels of the organization and efficiently coordinate activities with both internal and external stakeholders
- High degree of self-motivation
- Ability to quickly adapt to changing business conditions
- Demonstrated track record in attracting and developing talents
- PhD in Biological Sciences or Engineering degree; 15+ years of relevant experience including practical experience in leading a team developing manufacturing processes
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.
Company
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester.
- Website
- https://sana.com/
- Mini-site
- Sana Biotechnology
- Location
-
188 East Blaine Street, Suite 400
Seattle, WA 98102
US
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