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Principal Scientist, Drug Product Sterile Solutions

External
GSK logoGsk · - Pennsylvania - Upper Providence
Full-timeHybrid6d ago
Data AnalysisDocumentationSAFe
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Responsibilities

  • This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Design, plan and execute formulation and process development studies for sterile and complex drug products.
  • Interpret experimental results and provide clear recommendations to project teams.
  • Lead stability, compatibility, and container-closure assessments to support regulatory submissions.
  • Prepare technical reports, study protocols, and documentation needed for product development and transfer.
  • Work across functional teams and external partners to support scale-up, technology transfer, and launch readiness.
  • Mentor colleagues, review data quality, and contribute to continuous improvement of lab practices.
  • Opportunities to publish research and influence industry approaches.
  • Why You?
  • Basic Qualification
  • We are seeking professionals with the following required skills and qualifications to help us achieve our goals
  • PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline; or MS with 5+ years' relevant experience; or BS with 10+ years' relevant experience.
  • Experience in formulation and process development for sterile or complex drug products.
  • Experience designing and executing stability and compatibility studies.
  • Strong data analysis skills and experience interpreting physicochemical and analytical results.
  • Experience authoring technical reports and contributing to regulatory documentation.
  • Preferred Qualification
  • If you have the following characteristics, it would be a plus
  • Experience with biologics, oligonucleotides, or advanced delivery systems.
  • Experience with container-closure integrity and primary packaging assessments.
  • Experience with technology transfer and scale-up to manufacturing.
  • Experience statistical design of experiments (DOE) and technical risk assessment methods.
  • Experience contributing to regulatory submissions and responding to regulatory questions.
  • Strong collaboration and influencing skills in matrix team environments.
  • You must be able to work in a hybrid model (minimum two days onsite per week) and travel occasionally.
  • 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.
  • 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 ori

Benefits

Health insuranceParental leave

Additional Information

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 You will lead scientific work to develop safe, stable, and manufacturable drug product sterile solutions, including mAbs and oligonucleotides. You will design and run studies, interpret results, and make clear recommendations. You will work closely with colleagues across science, regulatory, and supply teams. We value curiosity, clear communication, and a focus on patients. This role offers growth, real impact on development programs, and the chance to unite science, technology and talent to get ahead of disease together.


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