Formulation Scientist
Description
· Production Plant Support (Maintenance, Optimization, Investigation, Root Cause Analysis) for Commercial Product Processes
· Transfer of New Products into the St. Petersburg Site Project Management of Product Updates and New Product Introduction and Large Capital Projects
· Process Analytical Technology Development and Implementation Development of Manufacture of Vegicaps® softgels
The Formulation Scientist provides support to proactive and fee for service development projects for the following:
· Development of Fill Formulations for the Softgel Dosage Form for Gelatin and Vegicaps® softgels
· Selection of Shell Mass Formulations and/or Development of New Shell Mass
· Formulations for Gelatin and Vegicaps® softgels
· Development of Color Formulations for Gelatin and Vegicaps® softgels
Develop formulations for the delivery of APIs in the softgel dosage form which includes but is not limited to the following activities:
· Solubility & Miscibility Screening
· Dispersion evaluations
· Excipient selection
· API characterization (e.g. particle size analysis, determination of polymorphs, etc.)
· Development of Lead and Backup formulations
· Temperature Cycling
· Water Uptake Evaluation
· Determination of Order of Addition of Ingredients
· Determination of Critical Parameters
· Conduct feasibility and robustness screenings of customer supplied fill formulation
· Conduct encapsulation trials for initial stability evaluations
· Evaluate, Source, and Order Raw Materials for Formulation Development Efforts
· Work with process engineering staff in the scale up of formulations from the benchtop
· Work with Project Management in supporting Proactive and FFS Development work in the development of scopes of work, timelines, and budgets
· Determine and acquire necessary equipment and/or equipment modifications to meet project requirements.
· Perform and/or participate in DOE studies to optimize processes.
· Writing batch paperwork, test protocols, and reports.
· Conducting literature and patent searches.
· Staging and monitoring of experiments.
· Keeping accurate and detailed records of experiments including results and conclusions.
· Provide reports and updates of projects and activities as requested.
· Comply with Health, Safety and Environmental responsibilities for the position.
· Other tasks as assigned.
· Work with minimal supervision
Qualifications
Education or Equivalent:
· Ph.D. in Pharmaceutics, Biochemistry, Chemical Engineering or related science 5-10 years of experience in Pharmaceuticals
Knowledge/Skills Requirements:
· 5 -10 years of pharmaceutical manufacturing, formulations, and laboratory experience Minimum of 5 Years of experience in the formulation of solution, suspension and semisolid formulations required
· Minimum of 2 years of experience with oral lipid based formulations required
· Experience with self micro-emulsifying delivery systems (SMEDS) and enhanced solubility systems (ESS) preferred Experience in cGMP/cGLP environment required
· Hands on experience with HPLC and/or UPLC required Hands on experience with benchtop formulation development required
· Thorough understanding of ICH, FDA, EMEA, and ANVISA guidelines and regulations
· Familiarity with potent compound containment engineering controls such as flexible containment systems, isolators, and downflow booths
· Proficient user of MS Office and Visio Familiarity with Statistical Software such as SAS JMP or Minitab Familiar with DOE and statistical techniques
Typing Skills:
· 40 words per minute
· Excellent verbal and written communication skills required.
Additional languages a plus:
· German, French, Italian, Spanish, Japanese
Physical/Mental Requirements:
· Ability to work effectively under pressure to meet deadlines.
· Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
· Individual will be required to work with potent compounds which will require use of PPE such as respirators and PAPR Be accessible to manufacturing, laboratory and office staff.
· Be able to use required office equipment.
