to know more about GSK Biopharm. #GSKBiopharm_Development 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 flexible hybrid working. Occasional travel may also be required.
As a Scientific Leader for Container Closure System (with a focus on sterile applications) development, you will be responsible for the design and development of container closure system solutions that support the breadth of GSK's new products portfolio in Research & Development. You will lead a team of dedicated Packaging Development Scientists focussed on robust project delivery from early development through to product launch.
Following successful candidacy, you will join a dynamic and growing team based in Upper Providence, Pennsylvania (US) and Hertfordshire, Ware (UK) that 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 Sterile Packaging Development team comprised of Packaging Development Scientists
- Provide leadership in the development and maintenance of packaging solutions intended for use as separate container closure systems or integrated into drug device combinations
- Conduct studies to qualify suitability of glass and elastomeric components of packaging systems for intended use
- Ensure development requirements to support qualification, registration and key launch events are met, these include;
- Recommend primary packaging components
- Recommend dosing system components, where applicable
- Ensure primary packaging specifications are maintained
- Manage, execute, or consult on change controls for primary packaging components within R&D
- Input into development and formal stability studies to confirm suitability of the drug product with the container closure system
- Complete (generate or review) the Container Closure Sections for regulatory submission of Clinical Trial Applications of commercial registrations
- Ensure that all activities within the team's scope are conducted to high scientific standards and adhere to regulatory expectations
- Input to experiment planning and scientific review of resultant experiments
- Ensure the principles of data integrity are followed in the conduct of experiment and reporting activities
- Manage the chain of custody for the data within own team or area of accountability and ensure suitability for its intended use (i.e., business decision making, regulatory agency engagement)
- Ensure packaging development solutions are balanced with business parameters for cost effectiveness, environmental sustainability, product quality and patient use
- Collaborate with multi-disciplinary teams within the GSK network, industry bodies external to GSK, supplying partners and academic institutions
- Provide development opportunities to own team members, align team's objectives to business priorities and provide input during appraisals
We are looking for professionals with these required skills to achieve our goals:
- B.S./M.S. degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, or related field or equivalent industry experience (with minimum 5 years' industry experience in package development)
- Experience with domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
If you have the following characteristics, it would be a plus:
Why GSK? Uniting science, talent, and technology to get ahead of disease together
- Package development experience within the pharmaceutical industry
- Knowledge of packaging materials, components, packaging evaluation techniques, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within Drug Product Development (R&D) and Global Supply Chain.
- Deep technical knowledge pertaining to the performance, characterisation, and regulatory compliance of packaging materials and processes used with sterile drug product applications (e.g., glass, elastomers, and plastics).
- Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
- Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, Medicine Process and Delivery, and technology transfer processes.
- Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
- Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
- Understanding of design control requirements associated with Medical Devices and Combination Products (Drug / Device combinations)
- Excellent written and verbal communication skills
- Ability to delegate and empower others while provide appropriate level of guidance
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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