Associate Director, Non-Viral Delivery

Associate Director, Formulations and Delivery

South San Francisco, CA

About 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.