Associate Director, Concept Development and Delivery

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We're uniting science, technology, and talent to get ahead of disease together.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

GSK's Packaging, Device and Design Solutions team is charged with the delivery of robust, patient-centric devices and primary packaging solutions to enable the effective delivery of novel pharmaceuticals across all modalities and routes of administration. Our group is a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection and, ultimately, the registrational submission and commercial supply.

We are looking for an enthusiastic Associate Director to integrate technical attributes, patient and user needs, business requirements, competitive landscape and technologies for drug-device combination (DDC) products. The candidate will support development efforts to improve probability of technical success of development programs through design of suitable molecules, formulations, packaging and devices for our increasingly complex DDC products. You will join a dynamic and growing team that are key to delivering an expanding portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Collaborate with internal teams within Discovery, Clinical, Commercial, Quality, Manufacturing Science and Technology, Regulatory and Drug Product Development to develop on-target patient-centric DDC products and ensure integrated product development.
• Systematically engage and influence early to understand the technical requirements and challenges, flesh out product concepts, get the designs right and proactively outline the investment requirements, tradeoffs, and risks for GSK portfolio.
• Identify technical risks, lead mitigation using testing and modelling to support device selection.
• Plan and execute engineering studies, device characterization, design verification and validation.
• Author and review key technical documentation and regulatory submission.
• Support industrialization and technology transfer of devices to manufacturing sites, including process development support, design for manufacturability and resolution of device-related challenges.
• Monitor industry trends, collaborate with academia, government organizations and professional consortiums associated with DDC products.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in engineering, materials science, pharmaceutics or a related technical discipline.
• 8+ years of experience in design and/or development of medical devices or drug device combination products.
• Experience with design controls, risk management, design history file requirements.
• Experience working with suppliers, contract manufacturers or external technology partners.

If you have the following characteristics, it would be a plus:

• Advanced degree (Master's or PhD) in engineering or a related field.
• Experience with parenteral delivery systems such as prefilled syringes, autoinjectors, on-body injectors and non-integral…