Prefilled Syringe Expert
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Dec 19 2022
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 office and from home. Occasional business travel may also be required.
GSK R&D is looking for an Associate Director, Sterile Packaging Expert in prefilled syringes (PFS) to work within the Packaging Development & Design group. 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 support to drug product development teams in R&D and to our Global Supply Chain network. Your role is critical to ensuring the PFS 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.
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. The responsibilities of the role include the following:
- Lead PFS technology selection as part of technical development teams
- Establish technical specifications for primary packaging formats ensuring operability with clinical and commercial sterile packaging processes
- Lead technical engagements with key suppliers providing a technical link between supplier capability and project teams
- Ensure the robustness of PFS platforms across the Drug Product/Primary Pack/Device combination design space at a commercial scale
- Detail and integrate complex technical work packages into the project development plan. Manage their execution to completion aligned to agreed timelines.
- Support qualification, registration, and ensure key launch events are met
- Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g., ISO 13485, 21CFR820, ISO14971 and 21 CFR820.30)
- Guide the Prefilled Syringe sourcing strategy with Global Supply Chain procurement and technical functions
- Input into the design of stability protocols to support development, formal and primary stability campaign
- Lead optimisation or root cause analyses in relation to PFS improvement opportunities
- Complete (generate or review) IND/NDA CTX/MAA Container Closure sections with supporting documentation
- Review of post launch primary packaging changes or stability issues, as needed or requested
- Implement globally harmonized and coordinated strategies for pack development activities
- Incorporate Inclusive Design considerations where appropriate
- Integrate industry and global developments in packaging, and their adoption to support NPIs
- Input into Group Quality Policies
- Influence environmental policy and strategy for packaging sustainability
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, with minimum 3+ years’ experience in parenteral package development, primarily in pharmaceutical industry
- Experience working with drug delivery devices, primary packaging, drug container interactions, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
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 product 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.
- Working knowledge of packaging materials, components, 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)
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.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-[Register to View] (US Toll Free) or +1 [Register to View] (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting [Register to View] site.