Formulations Scientist


Lexington, KY


The Senior Formulation Scientist is responsible for formulation development of sterile injectable dosage forms, from pre-clinical development through product commercialization.
  • Design studies related to pre-formulation and formulation of parenteral products, including solubility, pH solution stability, lyophilization, suspension development, polymer development and others that may impact the stability and delivery of the product.
  • Experimental design, data evaluation, generation of scientific reports, and coordination studies with other technical groups
  • Plays an important role in the scale-up and technology transfer process in collaboration with Manufacturing team
  • Investigates, troubleshoots and resolves issues associated with formulation studies and/or R&D pilot manufacturing
  • Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibilities for projects when necessary.
  • Consults and interacts with internal cross-functional teams and external clients and customers
  • Operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms (e.g. lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.)
  • Apply and provide feasibility assessment for a variety of scientific principles and concepts to potential clients, products and investigations.
  • Conducts literature searches to support formulation development and/or pilot manufacturing documentation
  • Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners
  • Assist, consult, and trouble-shoot during process transfer scale-up and validation activities
  • Interpretation of results and scientific information including proficiency in statistical evaluation of data and design of experiments.
  • Interact with cross functional departments including Business Development, Project Management, ARD, QC, Process Development, Quality, Operations and with external clients
  • BS in Chemistry, Biochemistry or Pharmaceutical Science or related discipline
  • 5+ years’ industry experience, focusing on developing parenteral, solid and/or other formulation applications
  • Desired Experience: working within a variety of dosage forms (i.e. parenterals, lyophiles, polymers, suspensions, drug delivery systems, etc.) design of experiments, statistics, and unique technologies
  • Desired Experience: lyophilization cycle development and suspension development
  • Desired Experience: work within a clinical/commercial manufacturing organization
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