Early Engagement and Deviceability Project Engineering Lead

GSK’s Packaging, Device and Design Solution 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.

This position is being created to establish within GSK the capability to integrate technical attributes, patient and customer needs, business requirements, competitive landscape and technologies for drug-device combination (DDC) products. We are looking for an enthusiastic development engineer or scientist to 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), or Waltham, Massachusetts (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.
• Lead device development workstreams and collaborate with colleagues in innovation, primary packaging, and full device development.
• Develop new practices to ensure sufficient early characterization of molecule 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 early 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.

Why you?

Essential Qualifications, Experience & Skills:

We are looking for professionals with these required skills to achieve our goals:

• B.S. Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemical Engineering, or related degree with 7+ years of experience
• M.S. Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemical Engineering, or related degree with 5+ years of experience.
• Ph.D. Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemical Engineering, or related degree with 3+ years of experience
• 5+ years’ experience with protein or small molecules formulation development of drug-device combination (DDC) products or medical devices and delivery technologies (industry or academia)

Preferred Qualifications, Experience & Skills:

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

• Awareness of device and primary packaging technology landscape and innovations.
• Experience in drug device combination for large and small molecules including long acting injectables, liposomes, pre-filled syringes, cartridges, autoinjectors, and on-body injectors.
• Awareness of regulatory pathways for combination products. Experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP.
• Experience of human factors / usability engineering (IEC 62366). Matrix leadership experience.
• Experience with the development of connected devices. Ability to quickly establish relationships with internal and external stakeholders. 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.
• Evidence of team working skills and flexibility.

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Why GSK:

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

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