GSK · 6 hours ago
Principal Scientist, Drug Product Steriles Primary Packaging
USA - Pennsylvania - Upper Providence
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expGSK is a global biopharma company aiming to positively impact the health of 2.5 billion people by the end of the decade. The Principal Scientist role focuses on providing packaging support for drug product development, ensuring compliance with regulatory standards, and leading packaging activities for various projects.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Ensure development requirements to support qualification, registration, and launch key events are met. Activities include, but are not limited to, recommendation of primary packaging components, completion of steriles injectables primary packaging specifications and testing, manage/complete stability packaging campaigns, and oversight of design verification and validation testing
Author IND/NDA CTX/MAA Container Closure sections with supporting documentation
Author design control documentation
Assessment of new materials, components, and technologies for both technical performance and cost effectiveness
Conduct packaging activities and support development/execution of strategies for package development and technology selection/application across the DDS, MPD, GSC, Commercial, and external interfaces to ensure effective product development support
Comply with global harmonized standards and coordinated strategies for pack development activities
Conduct packaging activities as needed to support product manufacturing and packaging
Apply project management skills to deliver priority tasks aligned to project and portfolio milestones
Assessment of external partners and collaborations
Leads the characterisation of the selected container closure system and its compatibility with the intended drug product – e.g., glass delamination, silicone distribution, USP/EP/JP/ChP Compliance, and Container Closure Integrity
Support the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development and provide guidance across teams, projects, and functional areas
Qualification
Required
BS (+6 years of experience), MS (+4 years of experience), or PhD (+0 years of experience)
Degree in Engineering or related scientific discipline
Three or more years of experience developing and implementing packaging solutions
Three or more years of experience interpreting and implementing regulatory standards for packaging
Preferred
PhD. in Engineering or related field
Experience with sterile pharmaceutical packaging
Understanding of design control requirements associated with Medical Devices and Combination Products (Drug / Device combinations)
Experience authoring IND/NDA CTX/MAA Container Closure sections with supporting documentation
Benefits
Comprehensive benefits program GSK offers US employees
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
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South China Morning Post
2026-01-08
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