Senior Analytical Chemist

1 month ago

Brampton, Ontario, Canada SUN PHARMA Full time

Job Summary

The Senior Analytical Chemist will be responsible for developing and validating analytical test methods and providing analytical support to product development chemists. This role requires a strong background in analytical chemistry, with expertise in gas and liquid chromatography, spectroscopy, and other analytical techniques employed in the 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.
  • 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.

Requirements

  • 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 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 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.

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.

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