Job Description

Job purpose
The main responsibilities of this position are to conduct analytical development and research to support development of new products. This work is conducted under supervision of the Supervisor and includes method development, validation, as well as testing marketed and prototype products required for product development. Work is completed in a timely manner ensuring departmental and corporate goals are being met.
Duties and responsibilities

• Perform testing using advanced GC/HPLC techniques as well as specialized testing using particle size analysis, in-vitro, spectroscopic analysis and other techniques as required
• Perform development /validation of new analytical methods (with guidance from senior R&D staff)
• Prepare method development, validation and other research reports.
• Perform release of R&D products and raw materials
• Participate in activities leading to product approval under the guidance of Senior R&D staff (ie. deficiency letter responses for chemistry issues, investigations, etc.)
• Assist with laboratory investigation activities
• Report and clearly document all research work performed
• Report GMP work in accordance with current GMP/GLP regulations
• Initiate and follow through with actions required for change controls
• Maintain a clean laboratory environment and ensure that safety regulations are followed
• Complete all training assignment and maintain personal training records.
• Flexibility to work shift schedules when required
• Other duties as assigned

Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications

• B. Sc. in Chemistry or related discipline and experience in a pharmaceutical-related field
• In-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
• Familiarity with modern computer assisted analytical instrumentation methods and with older techniques (i.e. titration)
• Experience with method validation and development activities
• Good knowledge and understanding of GMP-s and GLP-s, as well as with pertinent FDA and Health Canada guidelines
• Ability to clearly communicate and work effectively in a team-based environment
• Regular problem solving with significant degree of judgment coupled with excellent logical skills required. Problems typically include chemistry related issues (i.e. understanding the chemistry/degradation of the active), instrumentation related problems.

Working conditions
Generally, fairly pleasant surroundings. Occasional exposure to higher than normal noise levels. Frequent, daily exposure to various chemicals used in the testing of raw materials, components and finished products. Occasional exposure to unpleasant odors resulting from testing procedures. Fairly level temperatures. Mixture of standing and walking, some light lifting and/or movement of material/ instruments.
Physical requirements
Office based role

Skills Required