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Senior Formulation Scientist

2 months ago


Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled and experienced professional to join our team as a Senior Formulation Scientist in the Biopharmaceuticals department at GlaxoSmithKline. As a key member of our team, you will be responsible for leading the development of late-phase drug product formulations, manufacturing processes, and delivery systems for protein-based therapeutics and new chemical entities (NCEs).

Key Responsibilities
  • Design, plan, and execute studies for formulation optimization, process characterization, and in-use stability/compatibility evaluations.
  • Provide correct interpretation of results and perform complex data management and analysis.
  • Physicochemical and bioanalytical characterization of native and modified biopharmaceuticals and NCEs.
  • Author and execute non-GMP stability protocols to test quality and stability of product formulations.
  • Maintain accurate, complete laboratory records.
  • Develop sterile product manufacturing processes, scaling up, and transferring to manufacturing sites.
  • Author and review technical protocols and reports in support of projects in various stages of development.
  • Work closely with internal and external development support partners, as needed.
Requirements
  • PhD degree in Pharmaceutics, Biology, Biochemistry, Biotechnology, Chemistry, or Chemical Engineering with protein formulation and drug delivery development experience.
  • At least one year of experience in protein and peptide chemistry and formulation and biophysical characterization of biopharms.
  • Experience in authoring technical reports and regulatory documentation (IND/IMPD, BLA/MAA, etc.).
  • Preferred qualifications include experience with biophysical techniques for product characterization and stability evaluation, conventional and alternative biopharmaceutical protein formulation, and drug product development.
About GlaxoSmithKline

GlaxoSmithKline is a global biopharmaceutical company with a special purpose – to unite science, technology, and talent to get ahead of disease together. 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).

We are committed to creating a workplace 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.