Scientist/Sr. Scientist - Bioassay Development, Validation and Tech Transfer

Scientist/Sr. Scientist – Bioassay Development, Validation and Tech TransferAt 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&DThe Extended Characterization group of the Analytical Development Department within the Drug Development and Supply organization has an exciting opportunity for an enthusiastic and driven Scientist/Senior Scientist to join our Bioassay team. This lab-based position offers an exceptional opportunity to contribute to the development, automation, validation, and tech transfer of cell-based potency methods, which are vital to drug development and manufacturing processes. By joining our team, you will play a key role in delivering new medicines to patients while advancing your career in the biopharmaceutical industry.Key Responsibilities: Develop and validate cell-based bioassays used for characterization,Participate in early/late-phase validation and method transfer activities to commercial testing laboratoriesProvide scientific input on method development with a focus on MOA (Mechanism of Action) functional mechanismsCollaborate with biology SMEs (Subject Matter Experts) to establish cell-based methods suitable for GMP settingsEnsure laboratory compliance with regulatory standards, data integrity, safety and quality standards consistent with company policiesIdentify and address compliance issues in experiments and lab protocolsIndependently conduct and manage experiments with increasing complexityDesign, execute and accurately record experimental dataIdentify and troubleshoot problems during experiments, proposing solutions based on data and contributing to process improvementsCollaborate with data science and automation teamsFoster and maintain good relationships both within and outside of Analytical Development departmentBasic Qualifications:Ph.D. or Master’s degree in Biology, Biological Science or Molecular Biology with 2 years of experience, or Bachelor’s degree with 5 of experience in performing or developing cell-based potency methods in an academic institution, biotechnology, or pharmaceutical industryTwo or more years experience in cell biology experience with cell-based method development and troubleshootingTwo or more years of experience in cell-culture techniques, including culturing various immortalized adherent and suspension cell linesPreferred Qualifications:Understanding and experience in GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice)Experience with cell-based methods for Biologics, oligonucleotide and ADC (antibody-drug conjugate) therapeuticsAbility to independently conduct and manage experiments, as well as analyze and interpret dataExcellent communication and strong technical writing skills for documentationExperience with liquid handling automation instrument for performing sample preparations and/or cell-based assays (e.g. Hamilton, Tecan, HP D300e) is a plusExperience with cell line creation by gene transfection techniquesExperience with Flowcytometry/FACS will be a plusMaintaining and validating GMP compliant instrumentsExperience with Digital, Data and Analytics tools (e.g. Spotfire, PowerBI)#LI-GSKSkillsBiopharmaceuticals, Bioprocessing, Cell Line Development, Drug Development, Experimental Methods, Molecular Cell Biology, Pharmaceutical Industry, Pharmaceutical Manufacturing, Quality by Design, Regulatory Submissions, Simulation Models, Technical Writing, Technology TransferPlease 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 - View email address on click.appcast.io 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/ AgenciesGSK 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 SummaryLocation: USA - Pennsylvania - Upper ProvidenceType: Full time