Director, Sterile Packaging, Packaging Development & Design

Are you inspired by user-centered packaging and device solutions to meet the challenges of delivering life-changing medicines to patients? If so, this Packaging Development opportunity could be an exciting opportunity to consider.

GSK's Packaging and Device Design and Development 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.

The role is to be based at GSK's R&D site in Upper Providence, Pennsylvania (US) and can offer a flexible hybrid working environment to enable the ability to work in the lab, office and from home. Occasional business travel may also be required.

With a focus in steriles applications, GSK R&D is looking for an experienced primary packaging professional with expertise in the development of drug device combination products. The Director of Steriles Packaging will lead a new group within Packaging Development and Design supporting our portfolio of large and small molecule parenteral products. As a subject matter technical expert, your role is to work within a dedicated and specialist primary packaging function to provide best-in-class technical advice and solutions necessary to support drug product development teams in R&D and to our Global Supply Chain network. Your role is critical to ensuring the primary packaging technology solutions and their interfaces with drug products and device delivery systems work flawlessly through clinical and commercial supply. You will be working alongside a team of dedicated packaging and device development scientists and engineers focused on robust project delivery from early development through to product launch and will be responsible for development of staff.

Following successful candidacy, you will join a dynamic and growing team based in Upper Providence, Pennsylvania (US) and Ware, Hertfordshire (UK) who are key to delivering an expanding portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• Lead the specialist primary packaging team with a focus on technical solutions for drug device combination products
  
• Develop team members, propose development opportunities, and provide input during appraisals
  
• Lead the development or identification of innovative primary packaging solutions and direct their qualification for use within the business
  
• Lead the onboarding of new packaging suppliers and their integration into projects and capability builds
  
• Lead technical engagements with key suppliers providing a link between supplier capability and project teams
  
• Develop best-in-class and deep level materials science expertise within the Packaging Development & Design team (e.g., Glass, Elastomers, Plastics)
  
• Ensure selected packaging systems for use with drug products and integration with device technologies are balanced with user and patient needs
  
• Develop strategies for onboarding new packaging technologies in preparation for the future state of drug delivery in GSK
  
• Lead internal project review and stakeholder engagement discussion building business alignment
  
• Represent GSK and area of subject matter expertise on Industry panels and academic collaborations
  
• Author/Review design control documentation
  
• Oversight of experimental plans, design verification and validation testing
  
• Input into the Container Closure Integrity Testing strategy for novel packaging and combination product systems
  
• Support the development of strategy and technological solutions across the Drug Product Development, Project Management , Commercial, Global Supply Chain (GSC), and external interfaces to ensure effective Packaging Development delivery:
  
• Provide competitive advantage through packaging solutions
  
• Support the development and implement the execution of GSC Procurement strategies and sourcing groups
  
• Support the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development
  
• Input into Group Quality Policies
  
• Author/Review group level Standard Operating Procedures and Work Instructions
  
• Influence environmental policy and strategy for packaging sustainability
  

Why you?

Basic Qualifications:

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

• M.S. or B.S. degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, or related field with a minimum 5 years' experience in parenteral package development, primarily in pharmaceutical industry
  

Preferred Qualifications:

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

• Understanding of design control requirements associated with Medical Devices and Combination Products (Drug / Device combinations)
  
• Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, new technology introduction, and technology transfer processes.
  
• Demonstrated track record of accomplishment in delivering projects, working within a complex, multidisciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
  
• Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
  
• Strong knowledge of packaging materials, components design and manufacturing technologies, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within R&D and GSC.
  
• Demonstrated knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
  
• Knowledge of container closure integrity testing techniques appropriate to container closure system and intended application. Experience with technologies such as Helium Mass Spectrometry, Vacuum decay, high-voltage leakage detection, laser-based headspace analysis and dye immersion
  
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
  

Why GSK?

Uniting science, talent, and technology 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 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 impact the health of 2.5 billion people around the world in the next 10 years.

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

#CMCDevelopmentGSK

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 impact the health of 2.5 billion people around the world in the next 10 years.

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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