Principal Scientist, Early Engagement and Deviceability

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 development engineer or scientist to integrate technical attributes, patient and customer needs, business requirements, competitive landscape and technologies for drug-device combination (DDC) products.  The candidate will support deviceability efforts to improve probability of technical success of development programs through early evaluation and design of suitable molecules, formulations and devices for our increasingly complex DDC products. You will join a dynamic and growing team that are key to delivering an expanding portfolio.  The role is to be based at GSK’s R&D site in Upper Providence, Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may also be required.

In this role you will:

• Collaborate with internal teams within Discovery, Clinical, Commercial, Regulatory and Drug Product Development to develop on-target, patient-centric DDC products through early engagement.
• Develop new practices to ensure sufficient early characterization of molecule and formulation attributes is done to ensure compatibility with device requirements and that information available from early assessment is fed into device concept development and technology scouting. 
• Apply principles of product design and knowledge of patient needs to Quality Target Product Profiles (QTPP) to create a robust DDC product strategy and identify CMC critical path activities.
• Incorporate internal and external best practices and lessons learned from DDC products challenges into deviceability strategy.  
• Monitor industry trends, collaborate with academic and professional consortiums associated with deviceability.
• Collaborate with colleagues in innovation, primary packaging, and full device development to define problem statements, initiate technology scouting and contribute to determine probability of technical and regulatory success. 
• Co-ordinate feasibility assessments involving prototyping and lab testing activities to support device selection.

Why you?

Basic Qualifications:

• PhD in Biomedical Engineering, Chemical Engineering, Pharmaceutics, Biology, Chemistry, or related scientific discipline with 0+ years of protein or small molecules formulation, DDC products or medical devices and delivery technologies

OR

• Master’s degree in related scientific discipline with 5+ years of similar experience

OR

• Bachelor’s degree in related scientific discipline with 10+ years of similar experience

Preferred Qualifications:

• Experience in formulation and process development of small and/or large molecules.
• Experience in drug device combination including long acting injectables, liposomes, pre-filled syringes, cartridges, autoinjectors, and on-body injectors.
• Awareness of device and primary packaging technology landscape and innovations.
• Good understanding of physicochemical properties and biopharmaceutics.
• Experience in working within a product development matrix team.
• Networking skills through interactions across departments, divisions, and disciplines.
• Good oral and written communication skills.
• Working experience of managing multiple projects of varying complexity simultaneously. 
• Ability to synthesize and explain complex topics to non-experts and to management. 
• Ability to work in a complex matrix environment and to influence and lead others without hierarchical authority. 
• Strong time management / organizational skills. 

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver strong