Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 14 2024 Are you seeking an opportunity where you can grow your contributions to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this Analytical Chemistry Investigator role could be an exciting opportunity to explore. As an Investigator, you will design and perform quantitative and/or qualitative analysis using a range of classical and instrumental methods to support the product development of the next generation of GSK medicines with a focus on preparative chromatography. You will play a key role in guiding the next generation of GSK medicines to reach patients. This role will provide YOU the opportunity to contribute to analytical development and to progress YOUR career. Your responsibilities include some of the following: Progress and lead analytical aspects of projects utilising their substantial experience and expertise as part of a CMC Analytical team and wider matrix teams, plus any other tasks as requested by team leader or departmental director. Develop prep chromatography workflows for the isolation of API and related impurities. Development and validation of robust analytical methods for drug substance and/or drug product. Participate in technology transfers, qualifications and validation as appropriate. Independently write and edit sections for patents or regulatory submissions, authors scientific papers and internal reports Documents laboratory work in accordance with GxP expectations, company policy, and legal requirements. Review experiments, stability protocols, and other key documents Performs data management tasks including recording results effectively in a laboratory notebook or computer independently (e.g., tabulating and graphing results). Provides input and as appropriates leads in troubleshooting and problem-solving activities as they occur during the development process. Interprets results and forms conclusions to share with the project team and line management as appropriate. Provides scientific input and recommendations to the project team decision making process. Follows safety requirements for laboratory/working environment. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in Chemistry, or related scientific field with 7+ years of pharmaceutical industry experience OR an MS in Chemistry, or related scientific field with 5+ years of pharmaceutical industry experience OR a PhD in Chemistry or related scientific field with 1+ year of pharmaceutical industry or academic experience Experience with method development and/or validation and/or transfer and/or regulatory filings. Experience working with analytical techniques and laboratory procedures (example equipment include HPLC, GC, etc.) Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience working with SOPs and ICH guidelines. Thorough knowledge of how to analyze and interpret experimental data. Thorough operational knowledge of laboratory equipment (e.g. HPLC, GC, typical lab equipment). Experience working in a matrix team environment Experience with prep chromatography in a laboratory or plant environment. Experience working on Antibody Drug Conjugate projects. Thorough knowledge of cGMP requirements. Good working knowledge and experience in small molecule analytical techniques such as HPLC, UPLC, GC, dissolution, UV/Vis Spectrophotometry, KF, MS, NMR, IR, USP compendial methods and laboratory procedures. 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 laboratory systems (e.g. Waters Empower CDS and Labware). Experience with both small molecule and biopharm analytical development. Strong technical writing skills for documentation. Collaborates well with others in the group and across groups. 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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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