Principal Scientist- Sterile and Drug Product Development

Business Introduction

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


Position Summary

You will lead scientific work to develop safe, stable, and manufacturable sterile drug products, including long-acting injectables, mAbs and oligonucleotides. You will design and run studies, interpret results, and make clear recommendations. You will work closely with colleagues across scientific disciplines, regulatory, and supply teams. We value curiosity, clear communication, and a focus on patients. This role offers growth, real impact on development programs, and the chance to unite science, technology and talent to get ahead of disease together.


Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Design, plan and execute formulation and process development studies for sterile and complex drug products.-Develop/optimize long-acting injectables, antibody drug conjugate (ADC), protein or oligonucleotide formulations.

• Develop phase appropriate formulations to support clinical studies and ultimately commercialization.

• Interpret experimental results and provide clear recommendations to project teams.
  Lead stability, compatibility, and container-closure assessments to support regulatory submissions.
  Prepare technical reports, study protocols, and documentation needed for product development and transfer.

• Lead drug product development matrix teams and/or member of matrix teams supporting product development.

• Work across functional teams and external partners to support scale-up, technology transfer, and launch readiness, and participate in preparing regulatory documents.

• Contributes to Drug Product Development strategies.

• Propose and deliver innovative approaches to achieve project goals

• Mentor colleagues, review data quality, and contribute to continuous improvement of lab practices.

• Opportunities to publish research and influence industry approaches.

Why You?

This role is hybrid and located in the United States. You will be expected to work on-site part of the week, with flexibility to work remotely for other tasks. Reasonable travel may be required.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline; or MS with 5+ years’ relevant experience; or BS with 10+ years’ relevant experience.

• Experience in formulation and process development for sterile, long acting injectables, protein or complex drug products.

• Experience designing and executing stability and compatibility studies.

• Experience with Data analysis and interpreting physicochemical and analytical results.

• Experience authoring technical reports and contributing to regulatory documentation.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Experience with long acting injectables, ADC, biologics, oligonucleotides, or advanced delivery systems.

• Good understanding of physico-chemical, biological properties and biopharmaceutics.

• Experience in sterilization techniques.

• Familiarity with container-closure integrity and primary packaging assessments.

• Experience with technology transfer and scale-up to manufacturing.

• Knowledge of statistical design of experiments (DOE) and technical risk assessment methods.

• Experience contributing to regulatory submissions and responding to regulatory questions.

• Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.

• Strong collaboration and influencing skills in matrix team environments.

#LI-GSK

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. …