Scientist, Assay Development

COMPANY SUMMARY

Kriya Therapeutics is a transformative gene therapy company with the intent to expand gene therapy to broader disease indications leveraging in house manufacturing capabilities and novel therapeutic designs.

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with prevalent and severe chronic diseases. We target conditions where the underlying biology is well-understood, rationally designing gene therapies for metabolic and other inflammatory diseases . Our lead programs are focused on the treatment of metabolic diseases such as diabetes (Type 1 and 2) and severe obesity.

Our team is made up of leading scientific experts who are passionate about improving patients' lives and easing the burden of these life-changing disorders for patients. Kriya employees are motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need. Our leadership team has a track record bringing innovative new therapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies that significantly impact patient health and wellbeing.

OVERALL SUMMARY

We are in search of a highly motivated, detail-oriented scientist to join our Translational sciences team at redwood city site. This position is hand-on and requires intensive experience in assay development.

Essential Functions:

• Development, optimization and qualification of bioassay for the assessment of gene & antibody therapy product, lot release and stability testing.
• Conduct the analytical evaluation of AAV products including preparation of reference standards, assay development plans, DOE and statistics for data analysis
• Evaluate new assay technologies and innovate novel assay/methodologies that could improve existing analytical methods.
• Keep good lab notebook and experiment records. Authoring and review of SOPs, Development Report.
• Transfer of methods and training of staff within the in-house QC department.
• Participate and present in internal and external scientific meetings and conferences
• Other activities as may be assigned

Education:

• MS degree or equivalent with 5+ years relevant industry experience,
• PhD or equivalent with 2+ years relevant industry experience.

Skills and Requirements:

• Intensive experience in assay development following ICH/USP guideline.
• In depth understanding of the mechanism of action (MOA) of gene and antibody drug and experience in design, and development of potency assay.
• Experience in AAV gene therapy.
• Experience in mammalian cell culture, cell line generation and cell banking.
• Experience in antibody kinetics.
• Experience in HPLC, BLI, ELISA, SDS-PAGE, Capillary Electrophoresis.
• Familiarity with analytical ultracentrifugation is a plus
• Sound understanding of statistical methods/tools for data analysis
• Knowledge of FDA, cGMP, and ICH regulatory requirements for method development is required.
• Previous experience contributing to SOP development and regulatory filings.
• Team player, good interpersonal and organizational skills
• Excellent written and oral communication skills