Investigator - Particle Size, XRPD, and Combination Injection Device Analysis

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.

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Our approach to R&D

Role Summary

As an Investigator – Particle Size, XRPD, and Combination Injection Device Analysis, you will work within matrix teams to design and perform particle and device testing,   applying   and integrating results from a range of analytical methods and advanced mechanical testing equipment. This role focuses on developing and delivering robust testing procedures and data assessments that enable the selection and refinement of the next generation of GSK parenteral medicines and drug-device combination products. You will play a key role in ensuring that   optimal   combination injection device solutions are provided to patients through your   expertise   in injection device analytics, while working in compliance with GSK policies and applicable regulatory and quality standards.

Responsibilities include:

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

Building and   maintaining   your   expertise   in particle science and device testing to help drive innovation and efficiency in analytical development activities.

Performing and guiding cGMP analytical laboratory experiments and technical analyses to support device and formulation selection and development, including analyses to support release and stability of drug substance, drug product, and combination products.

Executing and/or supervising the execution of method validation experiments for particle characterization and autoinjector analytical methodologies   in accordance with   regulatory standards and Quality by Design ( QbD ) principles.

Participating in cGMP analytical method transfers from R&D to commercial quality control laboratories.

Independently writing and editing sections for patents or regulatory   submissions, and   authoring scientific papers and internal reports.

Documenting laboratory work   in accordance with   cGxP   expectations, GSK company policies, and legal requirements.

Reviewing experiments, analytical methods, method validation protocols and reports, stability protocols, and other technical documents for scientific quality and compliance.

Performing data management tasks, including effective recording of results in electronic laboratory notebooks or other approved systems (e.g.,   tabulating   and graphing results).

Providing input into, and where   appropriate   leading,   troubleshooting   and problem-solving activities as they occur during the development process.

Proactively learning, building, and applying prudent data solutions and AI tools to drive efficiency and consistency in daily operations, in compliance with GSK’s information protection, data privacy, and acceptable technology use policies.

Interpreting results, forming conclusions, and presenting findings to project teams and line management as   appropriate .

Following all safety requirements for the laboratory and working environment and contributing to a culture of safety and compliance.

Take a leadership role for safety, regulatory and compliance within their department

Lead small projects/project sub teams to achieve technical or business outcomes

Initiate new research directions and novel strategies to achieve “project” and department goals

Why You?

Basic Qualifications

We are looking for professionals with   these   required skills to achieve our goals:

BS in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, or a related scientific field with 7+ years of relevant experience; or

MS in Chemistry or a related scientific field with 5+ years of relevant experience; or

PhD with 1+ years of work experience or a PhD thesis focused on a related topic.

Experience with technical   expertise   and working familiarity with multiple analytical techniques and laboratory procedures relevant to particle characterization and combination device analysis.

Experience with, or awareness of, modern data-analytic approaches for analytical data analysis.

Experience serving as, or the ability to grow into, a subject matter expert for cGMP combination injection device analysis and particle characterization.

Preferred Experience

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

Detailed understanding of internationally   recognised   consensus standards relevant to autoinjector and on-body delivery device testing (e.g., ISO 11608) and particle size characterization (e.g., USP ), as well as related regulatory guidance documents.

Extensive experience designing and executing mechanical testing of injector devices using manual, semi-automated or fully automated testing platforms, and experience in particle size characterization and XRPD.

Experience customizing fixtures and jigs for mechanical and/or device testing.

Proficiency   in programming and automating measurements or data analysis.

Thorough knowledge of cGMP requirements.

Familiarity with FDA/EU/UK and ICH regulations and guidance, particularly related to analytical transfer and validation, critical quality attributes, and release and stability testing.

Experience with both small-molecule and biopharmaceutical analytical development.

Strong technical writing skills for documentation, regulatory content, and scientific communication.

Strong   track record   of multidisciplinary collaborations or experience working in matrixed teams.

Experience applying data-analytics and data-visualization tools to promote quality and consistency in analytical methods.

Experience with colloids and multiphase systems, with an understanding of the interplay of physicochemical properties and rheology on combination device performance.

Ability to collaborate effectively with colleagues in the group and across groups, contributing to an inclusive and respectful working environment.

#LI-GSK

Skills

Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Automation Technology, Bioprocessing, Data Analysis Tools, Drug Development, Laboratory Reports, Matrix Leadership, Method Development, Technical Problem-Solving

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.

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