Associate Director, Formulations and Delivery

5 days ago

South San Francisco, California, United States SonoThera Full time
About SonoThera

SonoThera is a pioneering biopharmaceutical company that has developed a groundbreaking ultrasound-guided non-viral gene therapy platform. This innovative platform enables the precise and non-invasive delivery of large payloads of diverse formats (DNA, RNA, and combinations thereof) to various organs in the body, providing durable expression and the ability to re-dose and dose titrate without off-target delivery.

Our company culture is built on a collaborative, interdisciplinary, and forward-thinking approach to addressing the challenges facing genetic medicine discovery and drug development. Headquartered in South San Francisco, CA, we are committed to making a meaningful impact in the field.

Job Summary

The successful candidate will play a crucial role in the Research team, focusing on the design, implementation, and oversight of pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities at SonoThera and its CDMO partners. This position will establish and lead the research staff within the formulation team, collaborating with cross-functional partners to manage resource allocations and enable portfolio progression.

Responsibilities
  • Provide leadership in formulations, bioconjugates, and process development, as well as in-house and CDMO manufacturing.
  • Conduct formulation testing, stability studies, and analytical method development to support product development.
  • Lead technical transfer of manufacturing processes to commercial manufacturing sites.
  • Identify, assess, and oversee various contract research organizations (CRO and CDMO) to complement internal capabilities.
  • Author sections in regulatory submission documents and support global filings.
  • Author technical reports and present at various technical and management meetings.
  • Train, mentor, and guide colleagues, and support employee development initiatives.
  • Contribute to a team culture that promotes collaboration, open communication, career development, excellence, ownership, curiosity, and inclusion.
Qualifications
  • PhD in Chemical Engineering, Bioengineering, or a related discipline with 8+ years of progressive relevant work experience, or M.S. (or equivalent degree) with 12+ years of progressive relevant work experience.
  • A proven track record in developing and scaling up formulations for non-viral gene therapy payload delivery and/or ultrasound contrast agents (i.e., microbubbles, nanobubbles).
  • Extensive knowledge and hands-on experience with equipment and processes commonly used for gene delivery formulations development.
  • Strong leadership skills with the ability to plan and achieve research goals in an organizationally diverse research environment.
  • Excellent project management and communication skills.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial launch.

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