Principal Scientist, Drug Product Steriles Primary Packaging Full-time

Principal Scientist, Drug Product Steriles Primary Packaging

Onsite role located at Upper Providence, PA

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.

Job Purpose:

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

Key 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.

Basic Qualifications:

• 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 Qualifications:

• 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.

Skills

Drug Delivery, External Manufacturing, Medical Device Evaluation, Molecular Modeling, Pharmaceutical Formulations, Pharmacokinetics, Product Design, Product Management, Product Planning, Product Strategies, Quality by Design, Regulatory Filings, Stability Testing, Technology Transfer

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.