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 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 <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. #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. 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 - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.