Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
You will lead primary packaging strategy and technical execution for sterile drug products. You will work with cross-functional teams across development, supply, quality and regulatory to select, test, and qualify container-closure systems. We value scientific rigour, collaboration, clear communication, and a practical focus on patient safety. In this role you will grow as a packaging expert while directly influencing product development milestones and regulatory submissions that bring medicines to patients.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Select and justify primary packaging components for sterile products and manage related specifications and testing.
- Plan, execute and interpret compatibility, stability and container-closure integrity studies for development and registration.
- Author container-closure and packaging sections for regulatory submissions and support responses to agency questions.
- Lead design verification/validation and support design control documentation for combination products and device interfaces.
- Assess new materials, components and technologies for technical performance, regulatory compliance and cost effectiveness.
- Work with internal and external partners to support technology transfer, manufacturing readiness and supply continuity.
Responsibilities
You will help ensure primary packaging supports product quality, patient safety and regulatory expectations. You will apply scientific judgement to packaging challenges and translate results into clear recommendations. You will keep records and reports clear and accurate. You will collaborate across functions and with suppliers to deliver milestones on schedule.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- BS plus six years, MS plus four years, or PhD with relevant experience in engineering, pharmaceutics, materials science, chemistry or a related discipline.
- Minimum three years’ hands-on experience developing and implementing primary packaging solutions for sterile drug products.
- Experience designing and executing stability, compatibility, and container-closure integrity studies.
- Experience interpreting and applying global regulatory standards for packaging and container-closure systems.
- Proven ability to author technical reports and sections of regulatory submissions.
- Strong collaboration and communication skills, able to work in cross-functional and matrix teams.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Experience with sterile parenteral packaging formats such as vials, pre-filled syringes, cartridges, and on-body or combination devices.
- Familiarity with design controls, medical device regulations and combination product submissions.
- Experience evaluating glass delamination, silicone distribution, extractables/leachables, and material compatibility.
- Demonstrated success in technology transfer to clinical or commercial manufacturing.
- Experience with supplier assessments and managing external development partners.
- Strong project management skills and ability to balance multiple priorities.
Working Arrangement
This role is hybrid with a requirement to be onsite at our US site on a regular basis. Typical expectation is roughly two to three days per week on site, with flexibility as business needs require. Occasional domestic or international travel may be required.
What we value
We aim to build an inclusive environment where people can do their best work. We welcome different perspectives, backgrounds and experiences. We look for people who are curious, accountable and who collaborate respectfully. If you want to help shape packaging strategies that support patient safety and product success, we want to hear from you.
How to apply
If this role matches your skills and ambitions, please apply now. Include a CV and a short summary describing how your experience aligns with the basic qualifications and key responsibilities. We look forward to learning about you.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected]
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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