Chemist, Analytical Development and Validation
· Education: Bachelor degree in Chemistry, Biochemistry or related discipline.
· Experience: Minimum of 3 to 5 years of pertinent analytical laboratory experience with UPLC and HPLC. Being familiar with dissolution and Waters Empower software is considered as an asset.
· English: Required bilingualism includes being able to write, read and understand documents inherent to pharmaceutical research.
· Skills, knowledge and aptitudes:
· Excellent knowledge of analytical chemistry, including Liquid Chromatography;
· Good knowledge of cGMP regulations and guidelines;
· Good knowledge of USP and European Pharmacopoeias;
· Good organizational and writing skills;
· Ability to adapt to change;
· Good interpersonal skills.
Under the supervision of the Head of Analytical Chemistry, the Chemist, Analytical Development and Validation is responsible for the development and optimization of methods and analysis with respect of current Good Manufacturing Practices (cGMP) regulations and guidelines.
· Develop analytical methods for assay and impurities for new drug substances and drug products;
· Improve current analytical methods (HPLC and dissolution);
· Conduct validation of analytical methods as per ICH guidelines and Standard Operating Procedures (SOPs);
· Participate in writing of analytical methods and validation reports;
· Participate in training of Analyst on new methods;
· Perform analysis of drug substances and drug products;
· Coordinate method transfer activities;
· Perform any other tasks deemed relevant by the management.
To apply: firstname.lastname@example.org
· Develop new or improve LC-MS/MS assays for compounds to be analyzed in biological matrices (serum, plasma, blood and tissue) including an extraction (wet chemistry) procedure.
· Ensure that the performance of the analytical methods meets the appropriate regulatory requirements (i.e. FDA, EMA, etc).
· Work with other Chemists to transfer methods into the production environment.
· Follow proper policies/procedures as outlined in SOPs (existing and those yet to be developed) and applicable regulations.
· Assist in failure investigation of analytical methods at the validation or production stages. Prepare investigational or final analytical report.
· Maintain R&D logbooks, troubleshoot problems and perform minor repairs.
· Apply universal precautions when handling biohazardous material.
· Provide scientific, technical, and regulatory advice on all aspects of the appropriate standards, complying with the appropriate GLP guidelines, protocols and SOPs
· Review and follow scientific literature. Communicate research findings to the scientific community by publications and to management by attending international scientific conferences, presenting research results, and writing papers for publications in scientific journals.
· Supervise junior personnel for the sample preparation, instrument operation, maintenance and trouble shootings.
· Ph.D. in Analytical Chemistry or closely related field, with a minimum of five (5) years or, M.Sc. with a minimum of eight (8) years of experience in bioanalytical method development and validation (LC-MS/MS) in the GLP environment.
· Expertise in the development and implementation of mass spectrometry-based assays for small molecules is required.
· Expertise in the wet chemistry and hand-on experience for sample preparation is required.
· Excellent troubleshooting skills of MS-based bioanalytical method are required.
· Experience in the MS-based assays of steroids is an asset.
· Solid knowledge and deep understanding of mass spectrometry is an asset.
· Experience in maintaining laboratories and equipment in GLP compliance is an asset.
· Proven supervisory/leadership, verbal and written communication, organizational, networking and team skills.
Status : Standard - Full-time
Location : 1405, boul. Du Parc Technologique, suite 250, Québec (Qc) G1P 4P5