Principal Scientist, Drug Product Steriles Primary Packaging

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.

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

• 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.

We 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.

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.

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 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…