Job Description DIRECTOR, PROCESS CHEMISTRY AND DRUG PRODUCT Day One Biopharmaceuticals is an emerging, mission-driven drug development company focused on identifying, evaluating, and commercializing novel treatments for pediatric oncology patients, with the goal of expanding benefits to patients of all ages. For more information, visit http://www.dayonebio.com . POSITION SUMMARY: The Director of Process Chemistry and Drug Product will provide strategic leadership and technical oversight for the development, scale-up, manufacturing, and transfer of small molecule APIs, ADC payload-linkers, and ADC conjugation, along with formulation and manufacturing of lyophilized and liquid parenteral drug products. This role involves leading technical oversight of global CMOs/CDMOs, managing cross-functional collaborations, and ensuring the delivery of high-quality clinical materials in compliance with regulatory standards. The Director will oversee API process chemistry and drug product manufacturing activities, working closely with internal CMC, regulatory, quality, and supply chain teams. As a key technical leader, the individual will drive CMC lifecycle strategies, continuous improvement initiatives, technology transfers, and process validation to support clinical and commercial assets. The role also includes authoring regulatory documents and ensuring GMP compliance. This position reports to the Vice President of CMC Technical Operations and offers remote work flexibility, with occasional domestic and international travel (~10%). ESSENTIAL DUTIES AND RESPONSIBILITIES: Small Molecule and ADC Process Chemistry Manage CMO relationships for small molecule manufacturing and ADC bioconjugation, including batch execution, deviation resolution, and continuous improvement activities. Provide technical oversight and troubleshooting for synthetic routes, impurity control, and process robustness. Lead development, optimization, scale-up, and transfer of small molecule APIs, payloads, linkers, and ADC bioconjugation. Author and review regulatory filings (IND, IMPD, NDA, MAA), including process descriptions, control strategies, and comparability assessments. Drug Product Development, Process Optimization & Manufacturing Lead formulation development and manufacturing of biopharmaceutical (ADC) parenteral products. Oversee formulation development and transfer of liquid and lyophilized drug products, including early and late-stage processes. Manage fill-finish CMOs to ensure successful manufacturing, GMP adherence, and issue resolution. Develop risk-based oversight strategies considering product lifecycle and regulatory expectations. Partner with CMOs on deviations, investigations, and change controls. Lead the evaluation of second-source CMOs based on capabilities and compliance. Drive technology transfer, scale-up, and process validation for clinical and commercial products. Cross-Functional and Strategic Responsibilities Participate in CMC and regulatory meetings, representing process chemistry and drug product operations. Develop risk assessments, technical plans, and manufacturing strategies for development and commercialization. Drive continuous improvement for efficiency, yield, and cost reduction. Support specifications, stability studies, and comparability programs. Collaborate with Analytical Development, Quality, Regulatory, and Supply Chain teams. QUALIFICATIONS Ph.D. in Organic Chemistry, Process Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 10 years of industry experience; MS/BS with 12 years considered. Expertise in small molecule API development, ADC chemistry, and parenteral formulation and manufacturing. Experience managing external CMOs/CDMOs for clinical and commercial supply. Strong knowledge of cGMP, ICH guidelines, and global regulatory standards. Excellent project management, problem-solving, and collaboration skills. Experience authoring/reviewing regulatory CMC documents. Ability to thrive in a fast-paced, solution-oriented environment. Additional Qualifications Lyophilization cycle development experience. Impurity profiling and analytical characterization of payload-linkers. Familiarity with sterile manufacturing risk assessments. Experience with late-phase process validation and commercial readiness for ADC or small molecule parenteral products. The above description outlines the general responsibilities and level of work for this role. INTERVIEW INTEGRITY We expect candidates to engage authentically and will conduct multiple interviews and background checks to ensure skills and values alignment. COMPENSATION AND BENEFITS The salary range is $215,000 - $230,000, with actual compensation depending on various factors. Visit https://www.dayonebio.com/benefits for benefits details. DISCLAIMER Day One is committed to mutual respect and equal employment opportunities. Employment is contingent on COVID-19 vaccination proof. We do not sponsor work visas currently. Unsolicited resumes from agencies will be considered property of Day One without fees. J-18808-Ljbffr
