Principal Scientist, Drug Product Steriles Primary Packaging

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 95,000 - 130,000; Full time

Job summary

GlaxoSmithKline seeks a packaging development professional to support DDS project teams, Clinical Supply Chain and Global Supply Chain from prototype evaluation to commercial launch.

You will lead packaging strategy, specify primary components, oversee sterile injectable packaging, stability campaigns, and verification/validation testing while aligning with regulatory requirements and cost-objective decisions.

Qualifications

• 3+ years developing and implementing packaging solutions.
• 3+ years interpreting regulatory standards for packaging.
• Degree in Engineering or related scientific discipline.

Responsibilities

• Ensure development requirements to support qualification, registration, and launch key events.
• Recommend primary packaging components and complete sterile injectable packaging specs and testing.
• Manage stability packaging campaigns and oversight of design verification/validation testing.
• Author IND/NDA CTX/MAA Container Closure sections with supporting documentation.
• Assess new materials, components, and technologies for technical performance and cost.
• Apply project management to deliver tasks aligned to project milestones.
• Support packaging strategies across DDS, MPD, GSC, Commercial and external interfaces.

Skills

Packaging solutions

Regulatory interpretation

Cross-functional collaboration

Education

Engineering degree (BS/MS/PhD)

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 documentationAuthor design control documentationAssessment of new materials, components, and technologies for both technical performance and cost effectivenessConduct 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 supportComply with global harmonized standards and coordinated strategies for pack development activitiesConduct packaging activities as needed to support product manufacturing and packaging.Apply project management skills to deliver priority tasks aligned to project and portfolio milestonesAssessment of external partners and collaborationsLeads 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 IntegritySupport the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development and provide guidance across teams, projects, and functional areas.Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: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:If you have the following characteristics, it would be a plus: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.#LI-GSKSkillsDrug 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 TransferPlease 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 - [e-mail] is an Equal Opportunity Employer. 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