Senior Analytical Chemist

4 weeks ago

Brampton, Ontario, Canada SUN PHARMA Full time

Job Purpose

The primary objective of this role is to design, develop, and validate analytical test methods to support product development. Key responsibilities include the development and validation of new analytical methods, preparation of protocols and reports, and other documents for regulatory submissions. The position requires testing of R&D batches, raw materials, and packaging components in accordance with GMP/GLP regulations. Work is completed with minimal supervision and must be completed in a timely manner. Additionally, the role involves participating in the training and coaching of new staff.

Duties and Responsibilities

  • Perform advanced testing using 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 minimal supervision.
  • Prepare method validation protocols, method development, and method validation reports independently.
  • 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, including OOS and laboratory incidents.
  • Report and 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.
  • Other duties as assigned.

Qualifications

  • B. Sc. in Chemistry or a 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 a main focus on analytical, organic, and physical chemistry.
  • Excellent knowledge of modern computer-assisted analytical instrumentation methods and 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, with the 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, instrumentation-related problems, 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.

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