Senior Engineer, Downstream Process Development

Location
South San Francisco, CA, United States
Posted
Apr 24, 2021
Ref
5044861002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

Sana Biotechnology has an exciting opportunity for a Downstream Process Development Senior Engineer. The Senior Engineer will focus on the development of downstream manufacturing processes to support production of novel therapeutic viral vectors. This role also has opportunities to lead external manufacturing efforts to produce key reagents for therapeutic ex vivo gene editing. The successful candidate will lead downstream development, optimization, scale-up, scale-down model qualification and technical transfer to GMP manufacturing in order to advance Sana's gene therapy pipeline from first-in-human through commercialization.

The successful candidate must also leverage Sana's internal capabilities as well as external collaborators to design novel and disruptive process platforms in order to enable significant process intensification for commercial GMP supply. This role is expected to closely collaborate with multiple teams across Research, Process Development, Analytical Development and Manufacturing.

DUTIES AND RESPONSIBILITIES
  • Design, implement and optimize 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 initial scale-down lab build-out and scale-up/Pilot Plant build-out
  • 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
  • Support technology transfer of processes into GMP clinical and commercial manufacturing

QUALIFICATIONS

Basic Qualifications
  • PhD in Chemical Engineering (or equivalent) with 2+ year experience in industry. BA or MS plus 7+ 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
  • Familiarity with established safety practices for working with live viruses, including hands-on experience with Biosafety Level 2 operations
  • Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail
  • Excellent verbal and written communicate skills for technical and non-technical audiences
  • Demonstrated strong critical thinking and organizational skills
  • Detail oriented, self-motivated, independent, flexible, and able to prioritize and manage several projects concurrently in a fast-paced start-up environment
  • Demonstrated ability to work in cross-functional teams as a strong team player as well as independently
  • Demonstrated ability to exhibit curiosity both with scientific rigor and relationships
  • Ability to engage in crucial conversations - providing and receiving feedback

Preferred Qualifications
  • Process development experience with live viruses as vaccines or gene therapy; for example: adenovirus, adeno-associated virus (AAV), lentivirus, 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 viral vectors