Homology Medicines seeks an outstanding analytical development scientist to aid in developing and refining analytical methods to characterize AAV vector products. The individual in this role will be a highly skilled, talented and motivated researcher who will focus on the analysis of research/development-grade vector samples using multiple innovative AAV-specific analytical methods to aid in defining the critical quality attributes of our novel AAV vector product. The Scientist will be responsible for assay development activities, design of experiments, outsourcing and managing external projects, as well as collaborating internally, demonstrating feasibility of novel analytical methods and facilitating the purchasing of any necessary equipment. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the ultimate goal to deliver products that transform the lives of patients.
Essential Functions and Duties
- Helps drive the scientific strategy for characterizing AAV vector products
- Develop new assays and explore innovative analytical techniques
- Plans, executes and manages research independently
- Generates, manages, evaluates, and maintains critical data in a highly organized manner
- Develops and performs in vitro potency assays (e.g. ELISA, FACS, luminescence, functional activity) using cultured mammalian cells to support product development
- Passages and maintains cell lines to support infectivity and potency assays
- Writes and reviews technical documentation (protocols and reports, SOPs, regulatory submissions, etc.)
- Assists with technology transfer to contract manufacturing organizations by generating data and reports as well as providing on-site technical support
- Identifies complex technical issues and implements solutions.
Skills and Experience
- BA/BS in Biological Sciences with 6+ years of relevant industrial experience in analytical method development, MS with 4+ years of relevant experience or PhD with 1-3 years of relevant experience
- Experience in the development and maintenance of mammalian cell lines for in vitro cell-based potency and activity methods.
- Experience with functional cell-based assay development (e.g. cytotoxicity, proliferation, ADCC/ADCP, CDC, cytokine release, other) and sample testing
- Experience in the development of AAV-specific potency and characterization methods, including cell-based potency, vector genome titer, infectivity by TCID50, infectious center assay, transduction assay, and viral capsid titer
- Able to effectively manage and prioritize multiple parallel laboratory activities is essential
- Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Experience working in Quality Control or understanding of GLP and GMP practices a plus
- Experience with method transfer to external testing organizations to support characterization and release of clinical stage products is preferred
- Independently motivated, detail oriented and good problem solving ability
Interested candidates should forward a cover letter and resume/CV to email@example.com.