Director, Analytical Development (AAV)

HireMinds is working with a preclinical San Diego-based biotech startup developing next-generation AAV-based gene therapies. They’re using their technology to address key limitations of current gene therapies to improve their efficacy and safety.

 

This Associate Director/Director will be responsible for leading and executing the analytical development strategy for our preclinical and clinical programs in development. You’ll lead an internal team and work in collaboration with our research group, process development group, and external manufacturing and analytical development partners. Your goal is to identify, develop, and implement appropriate analytical methods to characterize AAV based gene therapy products across our pipeline. 

 

We’re looking for a subject matter expert in current state-of-the-art analytical methods used to support biological products. You’ll identify and mitigate quality risks to enable successful product development, contributing to the preparation of quality sections of INDs and other regulatory documents. The successful candidate exhibits flexibility, creativity and a can-do attitude to enable efficient execution of company objectives. 

 

Responsibilities:

  • Lead analytical development strategy across internal programs

  • Design and execute activities required to seamlessly support multiple programs in preclinical and clinical development

  • Contribute to the generation of acceptance criteria for the release of drug substance and drug product. 

  • Formulate phase-appropriate stability program for products in clinical development

  • Identify and implement novel analytical technologies for finished products, in process methods, and starting materials

  • Lead transfer of methods to CDMO and provide subject matter expertise to enable successful transfer

  • Write/review method qualification and method validation protocols to ensure compliance with regulatory guidance

  • Alert decision makers and stakeholders to risks that can impact critical program timelines

  • Coordinate corrective measures across functions in cooperation with functions as needed

  • Stay current with emerging analytical technologies, regulatory guidance on gene therapies

  • Participate in scientific conferences and represent the company to the broader external scientific community

 

Requirements

  • PhD in cell/molecular biology/ Immunology/Biochemistry or related discipline with at least 5 years of industry experience in assay /analytical development for biological products with a minimum of 10 years of relevant experience.

  • Experience and demonstrated excellence in AAV gene therapy analytical development

  • Solid understanding of statistical methods

  • Ability to use scientific literature to design methods and troubleshoot problems.

  • Strong knowledge of GMP, GLP, ICH and other regulatory requirements for biological product characterization

  • Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success

  • Expertise in project management and outsourcing analytical activities with CDMOs

  • Ability to work in a matrix organization in collaboration with discovery research, nonclinical development, operations, clinical development and with consultants and external service providers