Director, Device Development and Commercialization Lead

Role Summary

Director, Device Development and Commercialization Lead. Lead the development and commercialization of a complex vaccine drug product device combination (Vax-31) through clinical development, regulatory submission, and launch, integrating cross-functional teams and external partners to meet milestones and compliance requirements.

Responsibilities

• Lead combination device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch and post market surveillance.
• Guide the DP team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and Part 820.3 and implement into the Combination Product program plan.
• Responsible for development of design control documents and maintaining design history file (DHF) and Device Master Record (DMR) for the Vax-31 vaccine product.
• Collaborate with internal cross-functional teams and external partners to develop and execute device specific plans to ensure clinical and launch milestones are met.
• Manage suppliers, device testing labs and Human Factors Engineering partners for ensure successful design verification and validation studies.
• Interact with the DP Technical Team and advise on late-stage development strategies for successful execution of Process Characterization studies and PPQ campaigns.
• Support the DP Technical Team in tech transfers of the process(es) for both late and early-stage programs to CMOs.
• Design and execute submission strategies for device related dossier components and support regulatory CMC activities.

Qualifications

• PhD with minimum 10+ years, MS with 12+ years, or BS with 16+ years of leadership experience in the development and manufacturing of injectable combination products.
• Experience leading device development projects in a cross functional matrix organization from concept, development through commercialization.
• Significant experience in managing and executing Design Control programs with biological molecules for combination products (drug device combo), preferably Pre filled Syringe.
• Experience with PCV/adjuvanted vaccines would be a distinct advantage.
• Experience of manufacturing within GxP environments either directly or through CMOs.
• Preferred experience in late-stage DP development, designing and executing PPQ protocols, ensuring that drug product manufacturing processes are robust, reproducible, and meet regulatory requirements.
• Track record of working seamlessly within and across Teams and Organizations to execute the Design Control process.
• Strong scientific leadership: critical thinking, ability to present complex data sets and independently propose and design follow-up studies.
• Lead, mentor and develop organization on device development best practices and strategies.
• Flexibility and organizational skills; ability to navigate multiple projects and timelines.
• Strong interpersonal skills; ability to communicate effectively both verbally and in writing to collaborate with DP technical team and other teams.

Skills

• Device development leadership
• Regulatory CMC compliance (21 CFR Part 4, 820.3)
• Design control, DHF/DMR management
• Project management in cross-functional matrix environments
• Vendor and external partner management
• Technical strategy for late-stage DP development and PPQ execution

Education

• PhD/MS/BS in a relevant scientific or engineering field with extensive experience in injectable combination products.