Principal Scientist, Drug Product Steriles Primary Packaging

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 90,000 - 130,000; Full time

Job summary

GlaxoSmithKline is seeking a Formulation Product Development professional to provide packaging support from prototype evaluation to commercial launch. You will work with DDS, Clinical and Global Supply Chain teams to define packaging strategies and ensure regulatory alignment for packaging components.

The role emphasizes development of sterile packaging, design control, and validation testing, with responsibilities spanning material assessments, cross-functional collaboration, and risk

Qualifications

• BS/MS/PhD with a strong foundation in packaging science or equivalent.
• Experience interpreting regulatory standards for packaging.
• 3+ years developing and implementing packaging solutions.

Responsibilities

• Lead packaging development activities to support qualification, registration, and launch milestones.
• Assess materials and technologies for technical performance and cost.
• Author container closure sections and design control documentation for IND/NDA CTX/MAA.
• Support project strategies for packaging across multiple functions and partners.
• Ensure compliance with global standards and packaging validation activities.
• Manage external partnerships and technology transfer efforts.
• Characterise container closure systems for compatibility with drug products.

Skills

Pharmaceutical Formulations

Product Management

Product Design

Quality by Design

Regulatory Filings

Stability Testing

Technology Transfer

Drug Delivery

Molecular Modeling

Product Planning

Product Strategies

External Manufacturing

Pharmacokinetics

Education

Bachelor's degree in Engineering or related scientific discipline

Master's degree in Engineering or related scientific discipline

PhD in Engineering or related field

Job description

Formulation Product Development

Understanding of actives, raw materials and their function and how they are brought together to form a stable, functioning product from prototype evaluation to commercial launch Job Family - Product Development: Manages or contributes to development of the company's products. Participates in international product teams to define and implement development policy and programs that best support the product strategy and future positioning of the organisation.

Job Family Group - Science and Technology

Designs and executes studies to discover, understand, model, simulate, and create new drug molecules. Research target identification, target validation, drug interactions with targets or receptors, and assay development. Maintains knowledge of competitive market conditions, patient requirements and technology advances.

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 Qualification

• BS (+6 years of experience), MS (+4 years of experience), or PhD (+0 years of experience).
• Degree in Engineering or related scientific discipline.
• 3+ years of experience developing and implementing packaging solutions.
• 3+ 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

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.

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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We are 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 place where they feel inspired, encouraged and challenged to be the best they can be. A place where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.