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Research and Development Chemist

GENERAL SUMMARY:

 
Applies scientific knowledge and experience to formulate laboratory scale batches and to develop and validate analytical methods, to be used for testing of active pharmaceutical ingredient and for Research & Development projects and after product approval.
 

PRIMARY RESPONSIBILITIES:

 
  • Develop new Veterinary Drug Product (Generic) to add to First Priority’s portfolio of products. This will include:
 
  • Develop formulations of Generic products.
  • Prepare lab scale batches.
  • Develop supporting analytical methods.
  • Oversee scaleup operations.
  • Assist in developing ANADA for submission.
  • Create forced degradation studies
 
  • Consult on the effect of changes to raw materials and the use of alternate raw materials in existing products.
 
  • Update and validate existing analytical methods to improve efficiency.
 
  • Support investigations into OOS, process deviations, and customer complaints.
 
  • Provide advice and training to QC Laboratory Chemists.
 
·        Assist as required with other duties as assigned by management.
 
 
QUALIFICATIONS:
 
Education and/or Experience:
 
  • Bachelor’s degree in Chemistry with 5 - 7 years’ experience in Pharmaceutical Formulation, Product Development, and/or Method Development or a Master’s degree in Chemistry with 2 -5 years’ experience in Pharmaceutical Formulation, Product Development, and/or Method Development. 
 
  • Demonstrated ability to work both independently and with a team.
 
  • Willingness to expand area of expertise.
 
  • De-formulation (reverse engineering) experience a must.
 
  • Formulation of liquids, suspensions and solid dosages a must.
 
  • Knowledge of GMP/GLP in lab environment a must.
 
 
 
 
Training:
 
·        Proficient in computer use including Microsoft Word, Excel, Power Point, Project and Adobe Acrobat
 
Reasoning Ability:
 
·        Ability to solve problems
 
·        Ability to work through issues and propose solutions without supervision.
 

WORK ENVIRONMENT:

 
·        Lab environment involving chemicals, solvents, gasses and glassware
 
·        Bench work and testing (up to 75% of work day)
 
·        Low to medium noise level
 
·        Temperature controlled environment
 
·        Pilot and production areas
 
 
TOOLS AND EQUIPMENT:
 
  • Computer and printer
  • Chromatography systems
  • IR and UV/VIS spectrophotometer
  • Viscometer
  • Conductivity/pH meter
  • Moisture analysis
  • Furnace, ovens, burners, etc.
  • Balances
  • Various other instruments and apparatus
  • Appropriate personnel protective equipment (when necessary)