Scientist, Analytical Development

JOB PURPOSE

Sana Biotechnology is looking for a highly motivated scientist to join a dynamic, rapidly growing, and collaborative team in the Analytical Development Group. This individual will be at the forefront of gene therapy approaches utilizing a novel biological platform, and we are seeking a creative and hardworking individual that shares our excitement in the potential of this platform. He/she will drive the development of potency methods for our gene therapy programs and contribute to the analytical characterization of viral vectors for in-vitro research-based experiments. The candidate will execute assay development and testing activities as well as cell process efforts that lead to a robust and scalable manufacturing process. This position represents an excellent opportunity for career development, working closely with experienced cell and gene therapy scientists in a highly collaborative environment.

DUTIES AND RESPONSIBILITIES

• Drive potency assay development for gene therapy programs, including flow cytometry, ELISA, Luminex or MSD, and gene expression assays.
• Develop MOA-reflective methodologies for use in both regulated (e.g. lot release, in-process, and stability testing) and unregulated environments (e.g. characterization, high throughput screening).
• Develop vector characterization assays, such as sizing and particle aggregation
• Develop, optimize, and execute robust and reproducible assays in support of both discovery research and pre-clinical development.
• Integrate data with cross-functional R&D teams and present data regularly at team meetings.
• Coordinate with various internal groups for evaluation of emerging vector products.
• Implement superb documentation of procedures and experiments to support tech transfer.
• Train and mentor junior associates.
• Contribute to Sana's mission and culture.

QUALIFICATIONS

Basic Qualifications

• Ph.D. in immunology, cell/molecular biology, virology or related field and up to 2+ yrs academic or industry experience. BA and/or MS plus 7+ yrs or equivalent combination of education and work experience.
• Strong knowledge of flow cytometry principles, method development & optimization and data analysis.
• Familiarity with development and /or qualification of cell-based and gene therapy therapeutics, including the development of analytical methods.
• Prior experience in development and execution of assays to characterize and measure proteins and DNA using a variety of methodologies including qPCR, ddPCR, electrophoresis, and ELISA.
• Excellent bench skills with attention to detail and high standards for data integrity and quality.
• Able to critically analyze data and troubleshoot methods and equipment.
• 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
• Demonstrated effective management of research associates.

Preferred Qualifications

• Experience with cell-based viral titration assays (e.g. flow cytometry, PCR, ELISA).
• Experience with viral vector systems, production and/or purification.
• Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan)
• Familiarity with GxP principles and regulations as demonstrated by assay and/or technology transfer to GxP manufacturing, or significant laboratory support of IND/BLA submissions.
• Experience in authoring and reviewing documentation including technical documents, protocols and reports connected to assay development, validation and sample testing in IND filing documents.

WORKING CONDITIONS

• Flexibility to work some evenings or weekends in support of cell culture processing
• Ability to travel

PHYSICAL REQUIREMENTS

Ability to perform assays, standard cell culture in a development lab.