Tekmira is a clinical and preclinical development stage biotechnology company with a prominent position in siRNA based drugs. A leader in developing effective molecular therapeutics treating a wide range of diseases, including cancer, metabolic disorders and infectious disease, Tekmira employs its proven nucleic acid delivery platform to deliver siRNA, systemically, to disease sites. The impact of our research is reflected by our strong publication record in high ranking peer-reviewed journals.
This is an opportunity to join our select team known for its scientific excellence and leading position in the development of siRNA therapeutics. As a Scientist, and an influential member of the team, you will be responsible for assisting in the development of methods to measure components of Tekmira’s siRNA therapeutics and their metabolites in biological samples. Additional responsibilities will include leading scientific research to identify and evaluate appropriate biomarkers of drug activity and safety to facilitate nonclinical and clinical monitoring and to further the understanding of mechanisms of action.
Duties and responsibilities will include
Reporting to the Director, Translational Research, and as a member of a multidisciplinary team you will:
Develop internally and/or coordinate with contract laboratories to develop methods to measure nucleic acid drugs and lipid excipients and their metabolites in biological matrices.
Develop internally and/or coordinate with contract laboratories to develop pharmacology and safety biomarkers to monitor activity and safety endpoints in nonclinical and clinical studies.
Analyse and interpret bioanalytical/biomarker data to support development programs and ensure compliance with regulatory requirements, validated methods and/or GxP quality standards.
Write and/or perform detailed review of study reports and technical documents, including method descriptions, method validation plans and reports, and bioplans and reports.
Establish product development plans, timelines and budgets for all bioanalytical and biomarker programs.
Assist in the identification and management of external collaborating partners; academic and/or contract research laboratories performing studies on behalf of the company.
Represent the department in project meetings and provide scientific leadership in bioanalytical/biomarker development throughout the drug development process.
Present results at internal and external meetings.
Contribute to the development of Tekmira’s patent portfolio and the scientific literature.
Opportunities for scientific leadership, project management and/or personnel supervision will be provided.
Ph.D. in Pharmaceutical Sciences, Bioanalytical Chemistry or a related field, or the equivalent combination of education and experience.
Minimum of 8 years of experience in bioanalytical and/or biomarker development and validation, including experience in the pharmaceutical industry or contract bioanalytical laboratories.
A creative scientific thinker with a strong understanding of small and large molecule bioanalytical approaches, including ELISA, CGE, HPLC, LC-MS/MS. A strong background in LC-MS/MS is preferred.
Exhibits superior knowledge of global regulatory guidance for bioanalytical and biomarker development and validation, and bioanalysis under GLP/GCP quality standards.
Enthusiasm for hands-on data analysis and laboratory benchwork.
Thorough understanding of the drug development process required.
Knowledge in drug metabolism and pharmacokinetics an asset.
Must have a keen sense of urgency and proven ability to work under strict deadlines and time pressures.
Superior analytical, organizational and communication skills (both oral and written) required.