VP, Vaccines Manufacturing

The company is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Vice President of Vaccine Manufacturing will work in partnership with the Senior Vice President of Technical Operations to provide leadership and management of the vaccine program with regard to manufacturing and supply strategy. In particular, the successful candidate will demonstrate a strong focus on technical leadership of vaccine program and guide the internal and external CDMO teams on scientific and technical development topics required for advancement of the program at the CDMOs.

The Vice President, Vaccines Manufacturing is responsible for driving end to end drug product manufacturing, and supply of clinical material at the contract manufacturing organizations. As a member of the Technical Operations Leadership Team, the VP is accountable for successful implementation of the Vaccine Manufacturing and life cycle operational plans at the CDMOs in alignment with Technical Operations vision and strategies. This leader will ensure that the network of contract manufacturing organizations responsible for product supply is well managed, fully compliant and operating effectively and efficiently.

Responsibilities:

·       Support the SVP in the development, evaluation and implementation of strategies and initiatives to advance the program

·       Provide scientific and technical leadership and oversight for the ongoing vaccine program at the CDMOs

·       Drive technical strategy for drug product development, manufacture, and fill finish operations of vaccine

·       Responsible for establishing specific objectives and timelines at the CDMOs, identify key scientific issues and critically assess scientific data to drive resolutions

·       Ensure quality and compliance, clinical supply, and robust and resilient operations at the CDMOs

·       Conceptualize and implement operational processes to maximize efficiency and manufacturing performance at the CDMOs

·       Deliver against business metrics to implement continuously improve operations at the CDMOs

·       Ensure rapid and effective resolution of technical, manufacturing and supply related issues

·       Ensure sharing and implementation of best practices across the CDMOs sites, especially within their technical operations network

·       Be an advocate for operational issues with the senior leaders within the company and with external partners as needed

·       Engage tactically with CDMOs on supply issues

·       Establish operational excellence and performance goals at the CDMOs

Education, Experience & Skills:

·       MS or PhD (preferred) in Chemical Engineering, Biotechnology, or related disciplines.

·       Minimum of 15 years of biopharmaceutical industry experience in Manufacturing environment with at least 10+ years of that experience focusing on technical operations and/or manufacturing of adjuvanted vaccines and sterile injectables.

·       Thorough understanding of technical areas related to processes, unit operations and functions involved in vaccines development and manufacturing

·       Technical experience with prefilled syringes is highly desirable

·       Knows and understands Quality compliance processes and regulations pertaining to production of sterile injectables (vaccines).

·       In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of vaccines.

·       Experience leading and managing complex manufacturing operations at the Contract Manufacturing organizations.

·       Demonstrated ability to establish collaborative, effective relationships with key external partners, including executive leaders of key CMOs and alliance partners.

·       Exceptional interaction, leadership and command skills with results-oriented focus is required.

·       Demonstrated change agility to successfully manage a high degree of complexity and multiple priorities.

·       Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise) and makes the best decisions for the whole.

·       Excellent influencing and negotiating experience and capabilities in a matrix environment.

·       Strong project management and execution skills and can manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.

Travel Requirements:

●      Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

●      Up to 5-10%.