Director of Gene Therapy Formulations

3 weeks ago

South San Francisco, California, United States HireMinds Full time
About Our Job

We are seeking a highly skilled and experienced Associate Director, Non-Viral Delivery to join our research team at HireMinds. As a key member of our team, you will play a crucial role in the strategic development, implementation, and oversight of pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities.

Key Responsibilities:

  • Lead efforts in formulation, bioconjugate development, and process optimization for in-house and CDMO 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 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.

Requirements:

  • 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 sections of regulatory documents from early-stage development to commercial launch.

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