Director, Drug Product

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the CMC strategy and implementation for small molecule programs from initial clinical development through to late-stage development, registration, commercialization, and lifecycle management.

• Direct phase-appropriate formulation and process development for oral solid dosage forms, which includes formulation selection, optimization, manufacturing process development, scale-up, and control strategies.

• Offer technical leadership for technology transfers, process characterization, process validation, and readiness for manufacturing.

• Choose, onboard, and provide technical oversight of CDMOs and external partners for drug product development, manufacturing, packaging, and related activities.

• Create work plans, timelines, budgets, and performance metrics for external partners, ensuring CDMOs are held accountable for quality, timing, and delivery.

• Supervise GMP manufacturing campaigns technically, which includes overseeing batch documentation, manufacturing performance, deviations, investigations, change controls, and corrective and preventive actions.

• Evaluate formulation, manufacturing, analytical, and stability data to identify trends, resolve issues, assess risks, and inform product and process decisions.

• Develop drug product manufacturing processes and control strategies that support quality, scalability, supply continuity, and regulatory requirements.

• Collaborate with Analytical Development, Quality, Regulatory CMC, Clinical Supply, and other CMC functions to establish integrated development, manufacturing, and supply strategies.

• Assist in clinical supply planning and execution by synchronizing development, manufacturing schedules, packaging, stability programs, and clinical timelines.

• Draft and review drug product sections of regulatory submissions, technical reports, development plans, specifications, risk assessments, and other CMC documentation.

• Adhere to FDA, EMA, ICH, cGMP, and global regulatory standards while supporting interactions with health authorities.

• Formulate and maintain program plans, budgets, timelines, and risk assessments; communicate issues and propose mitigation strategies.

• Articulate technical risks, recommendations, and business implications to cross-functional teams and senior leadership.

• Participate in technical due diligence, product evaluations, and overall CMC strategy development.

• Keep abreast of advancements in small molecule drug product development, manufacturing technologies, regulatory standards, and industry best practices.

• Assist in fostering a strong patient-centered culture within the department and the company.

• Report directly to the SVP, CMC and Supply Chain.

⛳️ Requirements

• An advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or a related field, along with 10+ years of pertinent experience in the pharmaceutical or biotechnology sectors; equivalent combinations of education and experience will be taken into account.

• Proven experience in leading therapeutic product formulation and process development.

• Extensive technical experience encompassing formulation development, process development, scale-up, technology transfer, process characterization, validation, and GMP manufacturing support.

• Background in supporting drug product development from early clinical phases to late-stage development and commercialization; experience with commercial launch or manufacturing is highly desirable.

• Demonstrated success in managing CDMOs and external development and manufacturing partners in a highly outsourced operating model.

• Strong foundational knowledge of drug product manufacturing processes, pharmaceutical analytical testing, stability programs, specifications, and control strategies.

• Capability to interpret complex manufacturing, analytical, and stability data and convert findings into sound technical and business decisions.

• Comprehensive understanding of cGMP requirements, ICH guidelines, and global regulatory standards for pharmaceutical development and manufacturing.

• Experience in authoring and reviewing CMC regulatory submission content and assisting with responses to inquiries from health authorities.

• Proven expertise in leading investigations, troubleshooting manufacturing and product performance challenges, and executing 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.

• Exceptional written, verbal, and presentation skills, including the ability to convey complex technical issues clearly to senior leadership.

• Comfortable working independently and being hands-on in a fast-paced, agile, and growing biotechnology environment.

• Successful completion of a background check.

🏝️ Benefits

• Discretionary annual bonus may be available based on individual and company performance.

• Equal opportunity employer.

• Full-time exempt position.