Sr. Director/Executive Director, Drug Product Development

Role Summary

We are seeking a strategic, highly skilled and motivated Sr. Director/Executive Director of Drug Product Development to join our dynamic team. The successful candidate will lead our efforts in the development and manufacturing of high concentration biologic drug products, with pre-filled syringes and autoinjectors intended as the final product presentation. The ideal candidate will be experienced in setting strategic direction and hands-on leadership of the development and manufacturing of biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability, combination product design, verification, and validation, and assembly, labeling, and packaging processes.

Responsibilities

• Champion the development of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use.
• Ensure rigorous design verification and validation studies are planned to meet all functional and safety criteria set by regulatory guidance from FDA, EMA and ROW.
• Manage the execution of human factors studies to evaluate the usability of combination products, focusing on enhancing user experience and safety.
• Leveraging the analysis of 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 to Phase 3/Commercial.
• Provide oversight of late-stage drug product development activities through to PPQ commercial supply readiness.
• Ensure implementation of robust quality control measures by CDMO partners to assure product quality, integrity, stability and compliance throughout the manufacturing process.
• Coordinate and facilitate technology transfer and ensure seamless integration of new products into production lines.

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

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

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

Qualifications

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

Location

This is a remote role; periodic travel to team and company events is required.