Director, Device Development and Commercialization Lead

Summary:

VAX-31 is an extremely complex biological product whereby numerous (31) Drug Substances are presented as an adjuvanted suspension Drug Product (DP). The complexity of the DP necessitates careful consideration for development of a pre-filled syringe (PFS) combination product for clinical and commercial use. Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development Team to drive this combination product through the development and regulatory stage gates required for commercial success and distribution.

The Vax-31DP is a suspension system, which generates a unique set of challenges for production, handling and testing. All these complexities present themselves within the combination device setting, and the incumbent will be tasked with managing these through their own team and within a matrix format through the wider DP/commercial organization. In addition, these complexities need to be understood, managed and presented to the regulators in convincing and coherent regulatory submissions. Because of these complexities, experience in the vaccine space, particularly adjuvanted vaccines would be a distinct advantage.

This is an SME position which is suited for someone who has significant late-stage experience in leading the technical combination product workstream for a PFS/biologic combination product.  Experience with combination product design control requirements and generation of associated documentation is required. As a core member of the DP Technical Team they will work closely with MSAT, CMO, Supply Chain, QC,  QA and Clinical teams to ensure the appropriate Device Design requirements, including formal verification testing are met for use in clinical studies and global marketing submissions. They will work closely with the Regulatory and Quality teams to ensure the appropriate 21 CFR Part 4 and 820.3 compliant documentation is produced to support both clinical studies, marketing applications and continued commercial life cycle management.

This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing and commercial readiness, be a crucial part of late stage enablement and long-term commercial success, which will affect millions of lives globally.

Essential Functions:

• 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.

Requirements: 

• 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.
• The candidate should have 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. This would include conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.
• The candidate should have a track record of working seamlessly within and across Teams and Organizations to execute the Design Control process.
• Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up studies.
• Lead, mentor and develop organization on device development best practices and strategies
• High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and DP technical team and well as across other teams.