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.