Senior Analytical Scientist

Job description

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 As a Senior Scientist in the Analytical Development department, you will design and perform experiments to develop, validate and transfer various analytical methods. You will be involved in all aspects of pharmaceutical development, including engagement with project teams and other stakeholders for projects in different stages of development. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and perform assays that support development, release and stability testing of pharmaceutical drug substance and drug products. Documents laboratory work in accordance with GxP expectations, company policy, and legal requirements. Review of experiments, stability protocols and other key documentation. Contribute to sections of patents or regulatory submissions as well as internal reports. Identifies and troubleshoots any problems in the execution of experimental processes; interprets results and communicates them to his/her supervisor. Provides scientific input and recommendations to the project team for analytical control strategies and influence decision making. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: BS in Chemistry, or related scientific field with 5+ years of relevant experience, or MS in Chemistry, or related scientific field with 3+ years of relevant experience, or PhD with no industry experience. Experience with method development & validation, pharmacopeia compliance and analytical lifecycle management. Technical expertise and working familiarity with several analytical techniques, and laboratory procedures. Experience with interpreting and communicating experimental data. Preferred Qualification If you have the following characteristics, it would be a plus: Knowledge of cGMP requirements Experience with analytical support of small molecule API and ADC drug linker intermediate development. Awareness with FDA/EU/UK and ICH regulations and guidances related to analytical transfer and validation and release and stability testing. Working knowledge and experience in small molecule analytical techniques such as HPLC, UPLC, GC, UV/Vis spectrophotometry, KF, MS, and laboratory procedures. Experience working with CRO's/CDMO's. Good technical writing skills for documentation and experience in regulatory documentation authoring. Ability to collaborate and communicate well with others in and across groups in a matrix environment. Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system). Data Analytics Skills: SQL, PowerBI, Spotfire #GSK-LI Skills Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Bioprocessing, Data Analysis Tools, Electronic Lab Notebook (ELN), Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), Laboratory Reports, Method Development, Technical Problem-Solving, Ultra Performance Liquid Chromatography (UPLC), Ultraviolet Visible Spectroscopy, Waters Empower 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/