Position Summary
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. 

Key Responsibilities
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.
  

Why You?

Basic Qualification
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.

Preferred Qualification
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 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.
  

Work arrangement
This role is hybrid. You will be expected on-site part of the week and may travel occasionally to suppliers or other sites.

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Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

 

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $142,725 to $237,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

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