Senior Research Associate, Process Development

JOB PURPOSE

We are seeking a talented and motivated individual to join Sana Early Stage Process Development team as a Senior Research Associate. This role will support process and product development and preclinical production of gene therapy vectors. It is a unique opportunity to establish a manufacturing platform for a novel biopharmaceutical modality and to advance lead candidates into clinical trials.

DUTIES AND RESPONSIBILITIES

• Plan and execute experiments to define unit operations for purification of lentiviral vectors (LVV)
• Develop clarification, chromatography, and ultrafiltration steps
• Identify and optimize key process parameters impacting yield and quality of LVV Drug Substance
• Perform formulation screening to improve stability and set expiry of LVV Drug Product
• Define hold times and storage conditions of process intermediates
• Characterize purity and biological activity of process intermediates using biophysical instruments and cell-based assays
• Measure process-related impurities
• Collaborate with the Upstream Process Development and Analytical Development teams
• Support Preclinical Operations to supply research materials for critical studies
• Support process scale-up and tech transfer to internal manufacturing and CMOs
• Interpret the results, perform statistical analysis and present data
• Perform housekeeping duties in the lab, including inventory, equipment maintenance and ordering supplies
• Maintain electronic notebook records
• Present results at group meetings
• Write development reports

QUALIFICATIONS

Basic Qualifications

• BS in Chemical Engineering, Biochemistry or a related field with 4 years of experience in biotechnology industry, or an MS degree with 2 years of experience.
• Ability to work independently in research laboratory settings under tight timelines
• Ability to design and execute experiments while maintaining detailed records
• Hands-on experience with cell culture, process chromatography, and Tangential Flow Filtration
• Programming and operation of bioprocessing and analytical equipment
• Strong analytical and writing skills
• 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

• Prior experience in process development or formulation development of biologics
• Comfortable with programming and operating high-throughput liquid handling robotics
• Working knowledge of the DoE approach to experimentation and statistical analysis
• Proficiency with tissue culture, bioreactors, AKTA chromatography systems, and membrane separations
• Knowledge of nanoparticle characterization methods
• Some experience with analytical methods: ELISA, qPCR, FACS, CE, Western blot
• Course work in molecular biology, cell biology, virology, biochemistry, and related subjects.

WORKING CONDITIONS

The incumbent should be able to operate safely in a BSL2 class laboratory environment and perform aseptic operations in a biosafety cabinet.

PHYSICAL REQUIREMENTS

The job will require to occasionally lift up to 50 lbs.