Associate Director, Non-Viral Delivery

Associate Director, Formulations and DeliverySouth San Francisco, CAAbout Our Client:Our client is at the forefront of developing a non-viral gene therapy platform capable of precisely targeting various organs in the body, delivering large payloads in multiple formats without the need for invasive procedures.Role Overview:The successful candidate will play a crucial role within the research team, focusing on the strategic development, implementation, and oversight of pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities. This leadership position will also involve building and managing the formulation team while closely collaborating with cross-functional teams to ensure resource alignment and drive the advancement of the company's research portfolio.Key Responsibilities:Lead efforts in formulation, bioconjugate development, and process optimization for in-house and CDMO (Contract Development and Manufacturing Organization) manufacturing.Design and conduct formulation tests, stability studies, and develop analytical methods to support the product's lifecycle.Oversee the technical transfer of manufacturing processes to commercial production facilities.Identify, evaluate, and manage external partners, including CROs (Contract Research Organizations) and CDMOs, to extend internal capabilities.Contribute to regulatory submissions by authoring technical sections and supporting global filings.Prepare and present technical reports and updates in various internal and external meetings.Mentor, train, and guide research staff, fostering a culture of continuous learning and professional growth.Promote a collaborative and inclusive team culture that values open communication, innovation, and high standards of excellence.Qualifications:PhD in Chemical Engineering, Bioengineering, or a related field with 8+ years of progressive experience, or MS (or equivalent) with 12+ years of relevant experience.Proven expertise in the formulation and scale-up of non-viral gene therapy payloads and/or ultrasound contrast agents like microbubbles and nanobubbles.In-depth experience with equipment and processes commonly utilized in gene delivery formulations.Strong leadership skills with a strategic mindset to set and accomplish research goals within a diverse team environment.Excellent project management and communication abilities.Ability to excel in a dynamic, fast-paced setting, maintaining flexibility, initiative, and efficiency.Experience in authoring, reviewing, and finalizing CMC (Chemistry, Manufacturing, and Controls) sections of regulatory documents from early-stage development to commercial launch.