The individual hired into this role will participate in the development and implementation of bioanalytical methods for AAV gene therapy products spanning preclinical and clinical stages. This includes the development, optimization, qualification, and execution of assays in support of non-clinical and clinical development of AAV-based products as well as transferring them to CROs for further validation. Proven track record of bioanalytical technical excellence in ligand binding assays and PCR based assays, Knowledge of drug development and life cycle management concepts and experience of GLP/GDP preferred. The ideal individual for the role will be highly organized with attention to details and a passion for learning and highly adaptable. This individual will work closely with other team members to execute the assays and support data analysis and presentation as needed. This role will provide the individual the opportunity to grow and develop while advancing Kriya’s pipeline from research into clinical phase development. The level of this position will be based on the final candidate’s qualifications.
• Implement, develop and qualify bioanalytical assays including but not limited to ELISA, MSD, and qPCR under direction of project leader.
• Conduct non-clinical and clinical sample analysis as directed
• Assist and may lead assay transfer to contract research organizations (CROs) and/or other labs in support of nonclinical and/or clinical studies
• Perform data analysis using appropriate software (such as SoftMax, Prism, etc.)
• Responsible for documentation of all project work in appropriate electronic and/or paper-based laboratory systems
• Responsible for reagent sourcing, receipt, storage, inventory and preparation as directed
• Responsible for maintenance of laboratory instrumentations as directed
• Maintenance of updated safety, compliance and SOP training
• Ability to work in a fast-paced team oriented setting with good communication skills
• Degree in molecular biology, biochemistry, or relevant discipline plus relevant working experience (years) in a pharmaceutical/biotechnology or CRO laboratory setting:
o Bachelor’s degree with 3+ years’ work experience
o Master’s degree 2+ years’ work experience
• Hands-on experience in bioanalytical method development, particularly in LBA, qPCR and immunogenicity assays.
• Must be highly organized with attention to detail
• Must have strong communication and interpersonal skills
• Highly adaptable to changes and fast-paced setting
• Positive attitude with a solutions based approach to challenges
• Prior experience in managing assay transfer preferred
• Knowledge of GLP, GCLP or similar practices preferred
• Must be willing to travel up to 15% (once COVID situation resolves)
This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.
To apply for this job please visit workforcenow.adp.com.