Director, Drug Product

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Drug Product based in France.** This is a senior, fully remote leadership opportunity focused on advancing small molecule drug product development across the full development lifecycle. The role will shape formulation, manufacturing, scale-up, technology transfer, validation, and lifecycle strategies across multiple programs. As the drug product subject matter expert, you will provide technical direction while overseeing external development and manufacturing partners. You will work closely with CMC, Quality, Regulatory, Analytical Development, Clinical Supply, and program teams to ensure reliable delivery of high-quality clinical and future commercial supplies. The position combines scientific depth with hands-on execution in a fast-moving, highly outsourced biotechnology environment. It offers significant influence over technical decisions, program strategy, risk management, and manufacturing readiness. ### Accountabilities - Lead drug product CMC strategy and execution for small molecule programs from early clinical development through late-stage development, registration, commercialization, and lifecycle management. - Direct phase-appropriate formulation and process development for oral solid dosage forms, including formulation selection, optimization, manufacturing process development, scale-up, and control strategy development. - Provide technical leadership for technology transfers, process characterization, process validation, manufacturing readiness, and related development activities. - Select, onboard, and provide technical oversight of CDMOs and external partners supporting drug product development, manufacturing, packaging, and associated activities. - Establish expectations, work plans, timelines, budgets, and performance measures for external partners while ensuring accountability for quality, delivery, and timelines. - Provide technical oversight of GMP manufacturing campaigns, including batch documentation, manufacturing performance, deviations, investigations, change controls, and CAPAs. - Analyze formulation, manufacturing, analytical, and stability data to identify trends, troubleshoot issues, assess risks, and guide technical and product decisions. - Develop scalable, phase-appropriate manufacturing processes and control strategies that support product quality, regulatory compliance, supply continuity, and future commercialization. - Partner cross-functionally with Analytical Development, Quality, Regulatory CMC, Clinical Supply, and program teams to align product development, manufacturing, and supply strategies. - Support clinical supply execution by coordinating development activities, manufacturing schedules, packaging requirements, stability programs, and clinical timelines. - Author and review drug product sections of regulatory submissions, technical reports, development plans, specifications, risk assessments, and other CMC documentation. - Apply FDA, EMA, ICH, cGMP, and other global regulatory requirements to development and manufacturing activities and support health authority interactions when required. - Maintain program plans, budgets, timelines, and risk assessments while proactively communicating issues and recommending mitigation strategies. - Clearly communicate technical risks, recommendations, and business implications to cross-functional teams and senior leadership. - Contribute to technical due diligence, product assessments, broader CMC strategy, and continuous improvement of drug product development practices. - Stay current with advances in small molecule drug product technologies, manufacturing approaches, regulatory expectations, and industry best practices while promoting a patient-focused culture. ## Requirements - Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or a related discipline, with 10+ years of relevant pharmaceutical or biotechnology industry experience; equivalent education and experience combinations may be considered. - Demonstrated experience leading therapeutic product formulation and process development programs. - Strong technical expertise spanning formulation development, process development, scale-up, technology transfer, process characterization, validation, and GMP manufacturing support. - Experience supporting drug product development from early clinical stages through late-stage development and commercialization; commercial launch or manufacturing experience is highly preferred. - Proven success managing CDMOs and external development/manufacturing partners within a highly outsourced operating model. - Strong working knowledge of drug product manufacturing, pharmaceutical analytical testing, stability programs, specifications, and control strategies. - Ability to interpret complex manufacturing, analytical, and stability data and translate findings into sound technical and business decisions. - Strong understanding of cGMP requirements, ICH guidelines, and global regulatory expectations for pharmaceutical development and manufacturing. - Experience authoring and reviewing CMC regulatory submission content and supporting responses to health authority questions. - Demonstrated ability to lead investigations, troubleshoot manufacturing and product-performance issues, and implement practical risk-mitigation strategies. - Strong scientific judgment with the ability to balance technical requirements, product quality, regulatory expectations, timelines, costs, and supply considerations. - Ability to influence cross-functional stakeholders and external partners without direct authority. - Excellent written, verbal, and presentation skills, with the ability to communicate complex technical matters clearly to senior leadership. - Comfortable working independently and taking a hands-on approach in a fast-paced, agile, and growing biotechnology environment. ## Benefits - Fully remote working environment from anywhere. - Full-time, exempt position with significant technical and strategic leadership responsibility. - Expected salary range of **$200,000–$260,000 USD**, with actual compensation determined by experience, qualifications, geographic location, and other job-related factors. - Potential discretionary annual bonus based on individual and organizational performance. - Opportunity to lead drug product strategy across the full development lifecycle, from early clinical programs through commercialization. - High-impact collaboration with CMC, Quality, Regulatory, Analytical Development, Clinical Supply, and program leadership teams. - Significant ownership of external CDMO relationships and manufacturing strategy. - Opportunity to contribute to technical due diligence, portfolio decisions, and broader CMC strategy. - Exposure to complex small molecule development programs and evolving pharmaceutical manufacturing technologies. - Equal opportunity workplace committed to a patient-focused and collaborative culture. - Employment offers are contingent upon successful completion of a background screening.