Director, Drug Product

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.

• 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.

• 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.

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