Sr. Research Associate, Viral Vector Purification Development

Job Summary:

The successful candidate will be integral part of a fast-paced and rapidly growing group of scientists and engineers developing processes for the manufacture of adeno-associated virus (AAV) vector products. The individual will be responsible for developing a platform downstream process to support Homology’s product pipeline. Responsibilities will include multiple aspects of viral vector purification via centrifugation, chromatography and membrane filtration. In addition, the individual will devise, conduct and assist with formulation studies and analytical testing to support all aspects of downstream development. In this position the individual will perform scale-up studies and lead aspects of technology transfer to contract manufacturing organizations. Critical to this role is the ability to concisely interpret and summarize data, and to be able to effectively communicate results through high quality technical reports and oral presentations.

Essential Functions and Duties:

  • Planning and execution of studies related to the recovery and purification of AAV from cell harvest through final formulation steps
  • Design of scalable chromatography and other purification unit operations with product quality, purity, recovery and manufacturability in mind
  • Pilot scale production of pre-clinical test articles
  • Analysis of process intermediates and final product via SDS-PAGE, ELISA and qPCR
  • Assist with technology transfer to contract manufacturing organizations by generating development reports and providing on-site technical support
  • Support of R&D groups via material production, testing and interpretation of results
  • Preparation and presentation of development studies. Authoring of associated technical reports, including CMC sections for regulatory filings
  • This is a hands-on laboratory position, and requires execution of laboratory experiments, good laboratory notebook practices and good writing skills

Skills and Experience:

  • BS (5+ years), MS (3+) or PhD (1+) years of directly related experience. Degree emphasis in Bio/Chemical Engineering, Biochemistry or Molecular Biology preferred
  • An understanding of purification of biologics or more specifically viral vectors, including process scale-up and tech transfer
  • Proficient with ÄKTA systems and UNICORN control software
  • Experience with high-throughput process development techniques and statistical design of experience (DoE) preferred
  • Knowledge of GMP/ICH/FDA regulations
  • Track record of completing deliverables within specified timelines
  • Ability to work effectively in a cross-functional team
  • Experience in technical transfer and working with Contract Manufacturing Organizations
  • Experience with executing analytical methods used to support biologics purification process development (e.g. SDS-PAGE with silver staining and/or western blot, ELISA, HPLC, etc.)
  • Self-motivated and a capability of working independently
  • Excellent problem solving abilities with the knowledge and experience to anticipate and resolve issues before they arise
  • A strong understanding of the fundamentals of chromatography and membrane separations is required
  • Hands-on experience with AKTA chromatography systems and filtration (TFF, NFF) apparatus is required
  • A thorough understanding of virus properties and experience with development of purification processes for AAV and other viral vectors is highly desirable
  • Strong verbal and written communication skills are integral to this position

Interested candidates should forward a cover letter and resume/CV to careers@homologymedicines.com.