Investigator - Cytokine Immunoassay Specialist

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Dec 20 2021 We are looking for a highly motivated, flexible and experienced scientist to join a team within the Bioanalysis, Immunogenicity and Biomarkers (BIB) department based in either Collegeville, PA, USA, or Stevenage, UK. In this role, you will be a subject matter expert on cytokine analysis for clinical studies, developing and validating multiplex cytokine panels, providing guidance to clinical teams as well as oversight of CRO partners running cytokine immunoassays to support studies across the portfolio. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Evaluate and standardize technology platforms and validate cytokine assay panels before tech transfer to CROs Establish strategic partnership with selected vendors for multiplexed cytokine assay support Provides technical SME supervision to ensure data quality and consistency, enabling comparison of data across different studies Provide in house support of niche assays such as high sensitivity assays Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/MS/PhD in Biology, Biochemistry, Immunology, or related discipline. 5-10 years' experience working in a regulated pharmaceutical or biotechnology environment with a thorough understanding of the drug development process. Thorough understanding of regulatory requirements for GLP and GCP analytical activities. Hands-on experience and theoretical understanding of clinical immunoassay development, validation and study support using various immunoassay platforms (ELISA /MSD /Quanterix), including multiplexed assays. Proven ability to provide technical expertise to clinical teams regarding assay/platform selection and data quality. Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence. Excellent communication skills - will need to interface between many functional areas including external suppliers, internal study teams, subject matter experts and Quality Assurance. Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent attention to detail - reviewing validation plans, study plans, validation, and bioanalytical reports Highly motivated team player with a proactive attitude, excellent organizational skills, and a demonstrated ability to interact effectively within a multi-disciplinary team, including external partners, are essential. Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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. 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