Experienced Director/Senior Director of Chemistry, Manufacturing, and Controls (CMC) - Small Molecule Development and Regulatory Affairs Leadership

Introduction to MOMA Therapeutics MOMA Therapeutics is a pioneering biotechnology company that is revolutionizing the field of oncology by developing innovative inhibitors of highly dynamic proteins, specifically ATPases. Our company is driven by a passion for discovering transformative medicines that can make a meaningful difference in the lives of patients. With a strong foundation in science and a commitment to excellence, we are poised to initiate clinical development for two promising programs in 2024. As we continue to grow and evolve, we are seeking a talented and experienced Director/Senior Director of CMC to join our development team and play a critical role in shaping the future of our company. About the Role We are looking for an exceptional leader to oversee our CMC activities, including drug substance, drug product, and analytical development. As a Director/Senior Director of CMC, you will be responsible for leading multi-disciplinary teams, collaborating with internal stakeholders, and partnering with external organizations to ensure the successful development and manufacturing of our small molecule programs. Your expertise will be instrumental in guiding our CMC program strategy, managing timelines and budgets, and ensuring regulatory compliance. If you are a motivated and experienced professional with a passion for CMC and a track record of success in the biotechnology industry, we encourage you to apply for this exciting opportunity. Key Responsibilities Lead small molecule CMC teams comprised of technical leads and key stakeholders to achieve program goals and objectives Establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team Oversee the execution of CMC-related development and manufacturing activities at external manufacturing partners, including technology transfer and on-site management Guide the authoring of regulatory filings, including INDs, and ensure compliance with regulatory requirements Identify CMC program risks and develop contingency plans to mitigate potential issues Represent the CMC function at the program level and collaborate with cross-functional teams to develop program strategies Forge close working relationships with external partners, consultants, and stakeholders to advance programs through clinical development Essential Qualifications At least 10 years of experience in small molecule CMC, including experience in an early-stage biotechnology company Proven track record of effectively collaborating with and managing CDMOs Experience authoring regulatory filings, including INDs Familiarity with solid oral dosage form development and regulatory requirements Working knowledge of regulations and guidelines for small molecule development Leadership experience, including leading teams and/or projects in a dynamic, fast-paced environment Advanced degree (MS/Ph. D. or equivalent) in chemistry, pharmaceutical sciences, or a relevant discipline Preferred Qualifications Subject matter expertise in Drug Product or Analytical method development Experience with CMC program management, including budgeting and timeline management Strong communication and interpersonal skills, with the ability to build relationships and collaborate with cross-functional teams Ability to work independently and make decisions with minimal supervision Strong organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously Career Growth Opportunities and Learning Benefits Work Environment and Company Culture MOMA Therapeutics is a collaborative and dynamic work environment that values innovation, creativity, and teamwork. Our company culture is built on a foundation of respect, trust, and open communication, and we are committed to creating a positive and inclusive work environment that supports the well-being and success of our employees. As a Director/Senior Director of CMC, you will be part of a talented and dedicated team that is passionate about making a difference in the lives of patients. If you are looking for a company that shares your values and is committed to excellence, we encourage you to apply for this exciting opportunity. Compensation, Perks, and Benefits MOMA Therapeutics offers a competitive salary and benefits package, including a range of perks and benefits that are designed to support the well-being and success of our employees. Our company is committed to providing a positive and supportive work environment that recognizes and rewards the contributions of our employees. As a Director/Senior Director of CMC, you will be eligible for a range of benefits, including health insurance, retirement savings, and paid time off. If you are looking for a company that values its employees and offers a competitive compensation package, we encourage you to apply for this exciting opportunity. Conclusion If you are a motivated and experienced professional looking for a challenging and rewarding opportunity in CMC, we encourage you to apply for this exciting role at MOMA Therapeutics. As a Director/Senior Director of CMC, you will have the opportunity to work on complex and challenging projects, collaborate with experienced professionals, and develop your skills and expertise in a dynamic and fast-paced environment. Our company is committed to excellence, innovation, and teamwork, and we are looking for talented and dedicated professionals who share our values and are passionate about making a difference in the lives of patients. Apply now to join our team and take your career to the next level. Apply for this job