Director of CMC

• Location: San Francisco, CA
• Working situation: Hybrid
• Level: Director

Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for treating neurodegenerative and neuropsychiatric disorders, they are at the forefront of groundbreaking discoveries in the neurology space. As the Director of CMC, you will be a key architect in shaping the future of neurological treatment.

The Director of CMC will lead a team in the development and manufacturing of small molecule drug substances. Your expertise will drive the successful progression of drug development programs, making a significant impact on patients' lives worldwide.

The Director of CMC will:

• Develop and execute a visionary development strategy aligned with our client's mission and goals, driving them closer to revolutionizing novel brain health therapies
• Lead a team of 3-5 direct reports that will participate in
• strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in
• Define and plan out strategies for development from Phase I to commercialization phases of the drug lifecycle
• Leverage your proficiency in small molecule drug development to drive and execute CMC development plans to support cGMP manufacturing
• Prepare and defend CMC regulatory documents enabling global filings
• Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to accomplish program goals
• Facilitate effective communication channels with external CDMOs/CMOs, providing clear project objectives, timelines, and expectations to partners, and actively participate in joint planning and decision-making processes for new drug substance synthesis

The Director of CMC has the following qualifications:

• 8 years of experience with small molecules
• 8 years of experience in contributing to CMC efforts from Phase I to Phase III (desired)
• Bachelor's Degree with 16 years, OR Master's Degree with 13 years, OR Ph.D. with 10 years of industry experience

Company Benefits:

• Competitive 401K program, health insurance, and HSA accounts
• Long-term incentives in terms of equity or stock at this level
• Hybrid role
• Paid holidays per year and Winter Break (typically between Christmas and New Year's Day)

If you are passionate about advancing neurological treatments through development excellence and excel in leadership roles, we encourage you to seize this chance. Embark on this transformative journey by applying today!