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Senior Engineer, Viral Vector Purification Development and Tech Transfer

Employer
Sana Biotechnology
Location
Seattle, WA; South San Francisco, CA
Start date
Nov 8, 2022

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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 an Engineer II / Sr. Engineer, Purification Tech Transfer, you will report to the Head of Purification Process Development and responsible for the technical transfer of viral vector purification processes to Sana’s CDMO partner. You must be detail-oriented, familiar with purification process unit operations and cGMP operations to support the transfer of early-stage viral vector purification manufacturing processes. You will work with a multidisciplinary group of engineers to prepare the technology transfer package and provide onsite support at the CDMO (person-in-plant). The candidate must collaborate effectively with cross-functional teams including Analytical Development, Supply Chain and External Manufacturing to coordinate critical deliverables. You will also provide manufacturing feedback to enable process improvements for next generations of viral vector purification processes to advance Sana's gene and cell therapy pipeline from first-in-human through commercialization. Cool stuff.

What you’ll do

  • Draft process transfer packages and other technical documents including SOPs, Master Batch Records, Bills of Material, Sampling Plans in close collaboration with the CMC and Process leads.
  • Provide onsite support at the CDMO, train new operators, and oversee process execution.
  • Primary technical point-of-contact for the CDMO.
  • Lead investigations to troubleshoot process execution challenges including RCA.
  • Communicate effectively and work collaboratively with external manufacturing partners.
  • Work with CMDO to develop strategies to meet program timelines.
  • Track CDMO technical performance and provide regular updates to program leads.
  • Develop workflows compatible with a cGMP environment.

What we’re looking for

  • Bachelor's plus 6+ years or MS with 4+ years or equivalent combination of education and work experience
  • >2 years of progressive experience in purification process development, including process transfers of clinical stage purification processes to external partners.
  • Experience with key purification unit operations, especially column chromatography
  • Well versed with cGMP requirements and working in a regulated environment.
  • Working knowledge of statistical design of experiments (DoE) and RCA
  • Excellent technical written and oral communication skills.
  • Effective collaborator with an agile mindset to succeed in a fast-paced, team-oriented organization.

What will separate you from the crowd

  • Demonstrated track record in development and tech transfer of early-stage viral vector purification processes to external CDMO partners
  • Familiarity with cGMP principles and regulations as demonstrated by technology transfer to GMP manufacturing
  • Experience with purification process control strategies
  • Proficiency in statistical design of experiments (DOE) and JMP software
  • Experience implementing novel purification manufacturing technologies

WORKING CONDITIONS

  • Travel up to 50% of the time (East Coast site)
  • Approximately 10% in-lab work
  • Some weekend work might be required
  • Work within a cleanroom environment

What you should know

  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC

 

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, 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.

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.

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.

Company info
Website
Mini-site
Sana Biotechnology
Location
188 East Blaine Street, Suite 400
Seattle, WA 98102
US

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