Sr. Specialist, Quality Control

Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

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. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary: 

We are seeking a Quality Control (QC) Sr. Specialist to join the QC team at Kriya Therapeutics.  This individual will be responsible for the technical transfer of new potency methods from Analytical Development into the QC laboratories, including ownership of the qualification protocols, procedures, training materials, testing, and long-term technical support.  The role will be responsible for the technical transfer of additional methods as new products are brought into the QC labs.  They will also own or support out of specification investigations, change controls, and other laboratory investigations, as needed.

     

Primary Responsibilities:

• Coordinate with Analytical Development to transfer new potency methods to the QC labs
• Own and execute method qualification/validation protocols
• Develop laboratory procedures, electronic notebook (ELN) templates, and supporting training materials
• Support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following quality procedures
• Develop, revise, and review general laboratory SOPs and stability protocols and reports
• Execute routine analytical testing
• Train and provide technical assistance and guidance to staff with regards to lab safety and analytical methods 
• Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

 

Required Skills:

• Minimum BS degree in Chemistry, Microbiology, Biological Sciences, or related field with 7+ years of relevant experience 
• Experience performing ELISA, PCR, and maintaining cell cultures
• Experience in developing materials and training QC Analysts in quality principles, procedures and analytical methods/equipment. Hands-on experience with analytical testing in a GMP or GLP environment
• Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations
• Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes
• Excellent and effective written, verbal communication and presentation skills

Kriya is an equal opportunity employer. 

We celebrate diversity and are committed to creating an inclusive environment for all employees.