Associate Director, Early Engagement And Deviceability Strategy

We are seeking 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 Drug Device Combination (DDC) products. You will join a dynamic and growing team that are key to delivering an expanding portfolio.

GSK's Packaging, Device and Design Solution (PDDS) 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 is a high-visibility, matrix leadership position that sits in our Early Engagement and Deviceability team.

The position is to be based at GSK's R&D site in Upper Providence, Pennsylvania (US), or Waltham, Massachusetts (US) and can offer work remotely two to three days a week. Occasional travel may also be required.

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, Regulatory and Drug Product Development to develop differentiated, patient-centric DDC products through early engagement.
• Lead device development workstreams and collaborate with colleagues in innovation, primary packaging, and full device development to enable device selection.
• 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 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?

Basic Qualifications

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

• Bachelors, Master's or PhD in Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemical Engineering, or related field

• Bachelor's Degree with 10+ years' experience, or Master's degree with 8+ years relevant experience, or PhD degree with 5+ years relevant experience

• Experience with protein or small molecules formulation development of drug-device combination (DDC) products or medical devices and delivery technologies.

Preferred Qualifications

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

• Knowledge 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.

• Knowledge of regulatory pathways for combination products.
• Experience 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 with 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.
• Experience managing multiple projects of varying complexity and ambiguity 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.

• Team working skills and flexibility.

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.

Find out more:

Our approach to R&D

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 stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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