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

GSK•Upper Providence, PA

18d

About The Position

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. 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.

Requirements

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.

Nice To Haves

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 <429>), 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.

Responsibilities

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