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Senior Research Associate, Upstream Process Development

Employer
Sana Biotechnology
Location
Cambridge
Start date
Apr 6, 2021

View more

Discipline
Engineering, Manufacturing & Production, Process, Science/R&D, Research
Required Education
Other
Position Type
Full time
Hotbed
Genetown, NextGen Bio

Job Details

JOB PURPOSE

We are seeking a talented and motivated individual to join the Upstream Process Development group as a Senior Research Associate. This role will contribute to upstream process development of our cell and gene therapy programs through phase 1. This role is for a creative and inquisitive engineer or scientist who will become a viral vector process development expert and drive establishment of our novel viral vector manufacturing modality.

DUTIES AND RESPONSIBILITIES
  • Develop robust and industrialized platforms and phase 1 processes for manufacturing novel pluripotent stem cell derived therapies and viral vectors for gene therapies
  • Use manufacturing experience to identify, optimize, and characterize key process parameters Perform screening DoE studies to confirm the impact of process parameters on yield and product quality attributes
  • Implement innovative, next generation technology for manufacture of viral vectors
  • Support tech transfer to the Pilot plant and CMO and support GMP operations
  • Support cross-functional teams in tech transfers and process validations
  • Support authoring documentation such as batch records, sampling plans, and development reports
  • Maintain a functioning bioprocess lab including equipment maintenance and critical supply management

QUALIFICATIONS

Basic Qualifications
  • Bachelor's in Chemical Engineering or related field plus 4 yrs or MS w 1-2 yrs or equivalent combination of education and work experience
  • Experience in manufacturing sciences, process development, manufacturing, or related areas.
  • Hands-on experience with bioreactor unit operations at bench and pilot scale
  • Demonstrated ability to work successfully in teams
  • Excellent communication, documentation, and presentation skills
  • Working knowledge of DoE methods for experimentation and statistical analysis
  • The candidate should be a team player, highly organized with excellent communication skills, demonstrate curiosity and scientific rigor and excellent problem-solving skills.
  • Ability to engage in crucial conversations - providing and receiving feedback

Preferred Qualifications
  • Demonstrated understanding of viral vector process development, characterization, manufacturing, and relevant biology. (AAV, Lentiviral vector, or other viral vector therapeutic modalities)
  • Demonstrated understanding of cell therapy process development, characterization, and relevant biology (pluripotent stem cells, differentiated cell types, T cells, HSCs, etc)
  • Experience with gene or cell therapy development
  • cGMP gene or cell therapy manufacturing experience
  • Demonstrated ability to work with and lead cross-functional teams and manage projects
  • Tech transfer and working with CMOs
  • Familiar with FDA and EU regulations and GMP standards.

WORKING CONDITIONS

This is a lab-based role, with occasional weekend work. Some travel may be required including tech transfer and CMO-related work.

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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