Principal Scientist, Drug Product Steriles Primary Packaging

GSK•Upper Providence, PA

2d•Onsite

About The Position

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 Job Purpose: To provide packaging support to the DDS project teams, Clinical Supply Chain, and Global Supply Chain network across modality types.

Requirements

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.

Nice To Haves

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.

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.