Job DescriptionThe 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