Job DescriptionDIRECTOR, DRUG PRODUCT TECHNICAL OPERATIONSDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.POSITION SUMMARY:The Director, Drug Product Technical Operations will provide strategic leadership and technical oversight for clinical and commercial small molecule development and manufacturing operations within the global CMO/CDMO network. This role will be responsible for ensuring the seamless execution of drug product manufacturing activities across the oral solid dose portfolio, collaborating closely with internal CMC, regulatory, quality, and supply chain teams.As a key technical leader, the Director will drive CMC integrated lifecycle strategies, continuous improvement initiatives, technology transfers, and process validation to support clinical and commercial assets. Additionally, this individual will play a critical role in authoring regulatory documentation and ensuring compliance with global GMP standards.This position reports to the Vice President of CMC Technical Operations and offers the flexibility of being fully remote, with occasional domestic and international travel (~10%) for in-person visits.ESSENTIAL DUTIES AND RESPONSIBILITIES:Drug Product Development, Process Optimization & ManufacturingProvide technical leadership in the formulation, development, manufacturing, and labeling and packaging of small molecule drug products.Lead clinical and commercial solid oral dose operations, optimizing process control strategies and quality oversight.Oversee process characterization and optimization for non-sterile oral solid dose formulations (tablets, capsules, and non-sterile oral suspensions, including intermediates that deliver these end products such as spray drying, hot melt extrusion, blending, tableting, and film coating).Develop and implement risk-based process control strategies to ensure process robustness, manufacturability, scalability and regulatory compliance.Design, optimize, and scale formulations for drug products to support clinical trials; ensure stability, bioavailability, and manufacturability; define critical quality attributes and process parameters.Lead process scale-up efforts and validation for small molecule drug products.Partner with CMC, regulatory, quality, manufacturing, and supply chain teams to support lifecycle management; drive process improvements, cost efficiency, and adoption of new technologies.CMO/CDMO Oversight & Technology TransferDevelop and manage risk-based strategies for oversight of CMOs, considering product lifecycle stage, complexity, and regulatory expectations.Oversee process and product monitoring plans, define and drive performance metrics, ensure alignment with quality systems and master documentation.Partner with CMOs to manage deviations, investigations, and change control activities, ensuring rapid and effective resolution.Serve as the technical lead for contract manufacturing oversight, ensuring adherence to GMP, ICH, and global regulatory requirements.Lead the selection and evaluation of second-source CMOs, assessing technical capabilities, quality systems, and compliance performance.Direct technology transfer activities, ensuring seamless scale-up and process validation for clinical and commercial oral solid dose products.Operational & Regulatory ComplianceProvide technical support for GMP manufacturing activities, including batch record reviews, deviation management, and lot disposition.Author/review CMC sections for IND, NDA, and post-approval changes, ensuring FDA, EMA, and ICH compliance. Act as SME for inspections and audits. Implement QbD principles.Develop and oversee drug product manufacturing budgets, aligning cost efficiency with operational excellence.Champion continuous improvement initiatives to enhance efficiency, reduce costs, and improve process robustness.Collaborate cross-functionally to align operational execution with business objectives and organizational goals.QUALIFICATIONSPh.D., M.S., or B.S. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field.10+ years of experience in drug product formulation and process development, and manufacturing within the pharmaceutical or biopharmaceutical industry.Expertise in oral solid dosage forms, including tablets, capsules and products for oral suspension (PfOS).Demonstrated success in technology transfer, process validation, and commercial launch of drug products.Deep knowledge of GMP manufacturing, regulatory compliance (FDA, EMA, ICH), and Quality by Design (QbD) principles.Proven experience in managing CMOs/CDMOs and global supply chains.Strong leadership, project management, and problem-solving skills.Experience working in fast-paced, dynamic small company environments.The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
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