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Senior Analytical Chemist
2 months ago
Job Summary
The Senior Analytical Chemist will play a key role in the development and validation of analytical test methods, providing analytical support to product development chemists. This position requires a strong background in analytical chemistry, with expertise in gas and liquid chromatography, spectroscopy, and other analytical techniques employed in pharmaceutical development.
Key Responsibilities
- Develop and validate new analytical methods with minimal supervision.
- 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.
- Test R&D products and raw materials as per specifications.
- Participate in activities leading to product approval under the guidance of Senior R&D staff.
- 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 assignments and maintain personal training records.
- Flexibility to work shift schedules when required.
Qualifications
- B. Sc. in Chemistry or related pharmaceutical discipline.
- Minimum five years of relevant experience in a pharmaceutical environment.
- In-depth knowledge of gas and liquid chromatography, spectroscopy, and other analytical techniques employed in pharmaceutical development.
- Sound knowledge of chemistry, with a 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 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.
