Associate Director, Concept Development and Delivery

GSK•Waltham, PA

7d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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 co-pack combination products.
Experience across multiple modalities (large molecules/biologics, small molecules and vaccines) and their specific delivery challenges.
Experience with relevant regulatory and quality frameworks for device and combination products with regulations and standards such as 21 CFR QSR, ISO 13485, ISO 14971 or equivalent.
Experience with simulation, modeling and familiarity with statistical analysis for design evaluation.
Experience supporting human factors engineering and usability testing.
Ability to work in cross-functional, global teams and communicate complex technical topics clearly to non-experts and to management.
Strong time management and organizational skills with ability to support multiple projects of varying complexity simultaneously.
Ability to work in a complex matrix environment and to influence and lead others without hierarchical authority.
Strong oral and technical writing skills with experience preparing protocols, reports and/or design documentation.

Responsibilities

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.