Sr. Director/Executive Director, Drug Product Development

Role Summary

Sr. Director/Executive Director of Drug Product Development to lead development and manufacturing of high concentration biologic drug products with pre-filled syringes and autoinjectors. Provide strategic direction and hands-on leadership for biologic combination product development, including formulation, fill/finish, primary containers, stability, design, verification, validation, and packaging processes.

Responsibilities

• Champion the development of the target combination product presentation (pre-filled syringe / autoinjector) and collaborate with internal and external resources to achieve a patient-ready product.
• Plan and execute design verification and validation studies meeting regulatory criteria from FDA, EMA, and ROW.
• Manage human factors studies to evaluate usability, safety, and user experience of combination products.
• Leverage study results to drive strategic improvements in product design and functionality.

• Identify and manage CDMO partners for drug-in-vial and combination product manufacturing.
• Provide oversight of development and manufacturing activities from Phase 1 through Phase 3/Commercial.
• Oversee late-stage drug product development through PPQ commercial supply readiness.
• Ensure robust quality control measures by CDMO partners to assure product quality, integrity, stability, and regulatory compliance.
• Coordinate and facilitate technology transfer and seamless integration of new products into production lines.

• Develop and execute the strategic vision for dosage presentation changes from vial to combination product, aligning with business needs and industry trends.
• Collaborate with external partners and internal functions to align Drug Product development activities with strategic clinical development goals.

• Lead the design and execution of studies supporting process validation for combination products to ensure robust, scalable manufacturing for commercial production.

• Ensure all development activities adhere to regulatory guidelines.
• Lead preparation and maintenance of documentation for regulatory submissions and audits.

Qualifications

• Director: Ph.D. in Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or related field with 12+ years of Drug Product Development experience focusing on high concentration biologic combination products with pre-filled syringes and autoinjectors.
• Executive Director: Ph.D. in Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or related field with 15+ years of experience in drug product development for high concentration biologic combination products.
• Proven executive leadership in development processes and regulatory compliance for combination products.
• Experience leading workstreams including container evaluation, contract manufacturer oversight, platform technology evaluation, design control, verification, validation, and human factors engineering.
• Demonstrated success in late-stage process validation studies.
• Strong strategic vision, problem-solving, leadership, and executive communication skills.

Skills

• Strategic program leadership for complex biologic combination products
• Regulatory awareness across FDA/EMA/ ROW for combination products
• Design control, design verification/validation, and human factors engineering
• Technology transfer and CDMO management
• Quality systems and GMP compliance
• Cross-functional collaboration and external partner management

Education

• Ph.D. in Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or related field (as specified above)

Additional Requirements

• Remote role; periodic travel to team and company events required