Associate Director, Formulations and Delivery

About SonoThera:
SonoThera is a venture backed early stage highly innovative biopharmaceutical company that has developed a novel ultrasound-guided non-viral gene therapy platform to provide patients with the next generation of genetic medicines. Our platform can precisely and non-invasively target almost any organ in the body to deliver very large payloads of diverse formats (DNA, RNA, and combinations thereof) that provide durable expression with the ability to re-dose and dose titrate and without off-target delivery.
Our corporate culture is driven by a collaborative, interdisciplinary, and forward-thinking approach to solving many of the current challenges facing genetic medicine discovery and drug development. SonoThera is headquartered in South San Francisco, CA.
Job Summary:
The successful candidate will be an essential part of 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 it's CDMO partners. The position will establish and lead the research staff within the formulation team. The job will require collaboration with cross functional partners to manage resource allocations to enable portfolio progression.
Responsibilities:

• Provide leadership focusing on 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 process to commercial manufacturing site.
• Identifying, 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 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.

No unsolicited agencies
Compensation: The salary range for this position is $170,000.00 to $215,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.
Benefits
At SonoThera, we'll give you the tools to feel healthy, happy and secure.
Equity and ownership in a fast-growing company.
Access to a 24-hour gym
♥ Comprehensive medical, dental, and vision
Commuting stipend based on your geographical location
401(k) Match: SonoThera offers a company match
All full-time employees are eligible for flexible Paid Time Off
Equal Opportunity for Diversity & Inclusion
SonoThera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.