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.

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.

Additional Requirements

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