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)