CMC Program Manager

Faeth Therapeutics is a biotech start-up founded in 2019 by an international group of world-leading cancer research scientists. Faeth’s mission is to use a deep mechanistic understanding of cancer metabolism to rethink the treatment of cancer. Faeth’s culture emphasizes humility, collaboration, and creativity.

We are looking for a highly self-motivated CMC Program Manager to join our team. This role will be pivotal in managing all aspects of company CMC, with a focus on small molecule drugs. This position will collaborate with cross-functional teams and consultants/CROs to ensure the successful development, manufacturing, and regulatory approval of our products. This is a unique opportunity to join our early team and pioneer the discovery of a new generation of therapeutic interventions for cancer.

Responsibilities:

• Provide technical oversight of CMC activities, including process development, manufacturing, and analytical testing.
• Identify and mitigate risks associated with CMC activities, proactively addressing challenges that may impact project timelines or regulatory approval
• Manage clinical supply, forecasting, and distribution activities in collaboration with CROs
• Ensure the implementation of robust and scalable manufacturing processes for phase 3 and commercialization
• Develop and implement CMC strategies aligned with overall program development timelines
• Lead CMC regulatory affairs activities, ensuring compliance with global regulatory requirements
• Prepare and review regulatory submissions related to CMC, including INDs, NDAs, and variations
• Communicate CMC strategies, timelines, and risks to senior management and stakeholders

Requirements:

• Bachelors in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, PhD preferred
• At least six years of relevant experience in CMC within the biotechnology and pharmaceutical industry
• Demonstrated success in leading CMC-related submissions and interactions with regulatory agencies
• In-depth knowledge of GMP and regulatory requirements for product development

Working at Faeth

Benefits:

• Competitive salary and meaningful equity in a well-funded, early-stage startup
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents, with 99% of premiums fully funded by the company
• Unlimited PTO
• Generous parental leave
• Quarterly offsites across the world with the team (when Covid permits :))
• 401K and ROTH Contribution Opportunities
• Mission oriented, remote first culture

Faeth was founded in 2019 by Siddhartha Mukherjee, oncologist and Pulitzer Prize winning author, Karen Vousden, Chief Scientist of CRUK & Lew Cantley, Director of the Meyer Cancer Center at Weill Cornell among others. Faeth’s investors include Khosla Ventures, Future Ventures, Digitalis and many more.

We are an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.