Senior Research Associate, Process Development

Location
Cambridge
Posted
Jan 09, 2021
Ref
5025413002
Required Education
Bachelors Degree
Position Type
Full time
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.