Sr Analytical Chemist

Job purpose

The main responsibilities of this position are to develop and validate analytical test methods and provide analytical support to product development chemists.  Key duties include development and validation of new analytical methods, preparation of protocols and reports, and other documents for regulatory submissions. Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed.  Work is completed with little supervision/guidance in a timely manner.  Participate in the training/coaching of new staff.

Duties and responsibilities

• Perform testing using advanced GC/HPLC techniques as well as specialized testing using particle size analysis and other techniques as required
• Develop, validate and document new analytical methods with minimum supervision.
• Independently prepare method validation protocols, method development and method validation reports
• Research and prepare drug product and drug substance specifications
• Perform compendial method verifications and validations as per protocol
• Perform testing of R&D products and raw materials as per specifications
• Participate in activities leading to product approval under the guidance of Senior R&D staff (ie. deficiency letter responses for chemistry issues, investigations, etc.)
• Function as the Analytical Project Lead for select development projects.
• Conduct laboratory investigation activities (OOS, laboratory incidents etc.)
• 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
• Complete Corrective and Preventative Actions (CAPA’s)
• Participate in the training of new staff
• 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

Qualifications

• B. Sc. in Chemistry or related pharmaceutical discipline
• Minimum five (5) years of relevant experience in a pharmaceutical environment.
• In In-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
• Sound knowledge of chemistry, with main focus on analytical, organic and physical chemistry
• Excellent knowledge of modern computer assisted analytical instrumentation methods and with older techniques (i.e. titration)
• Good knowledge and understanding of GMP-s and GLP-s, as well as with pertinent FDA and Health Canada guidelines
• Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment
• Regular problem solving with significant degree of judgment coupled with excellent logical skills required.  Problems include both routine and non-routine tasks, such as chemistry related issues (i.e. understanding the degradation pathway of the active) instrumentation related problems (understanding symptoms of HPLC problems and eliminating/repairing them) and first review of out-of-spec investigations.

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.