Stability Lead- Nanaimo, BC
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
Reporting to the Site Quality Control Manager, the Site Stability Lead will support operational and technical aspects of clinical/commercial drug substance, drug product, reference standard, and placebo GMP stability programs at the site. The successful candidate will have responsibilities is to ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and global regulatory guidelines. This includes design of stability protocols, retest/expiry dating for clinical and commercial products, providing stability sections for regulatory submissions, technical assessment of stability data, specification changes and investigations.
Roles and responsibilities
- Ensures statistical methods comply with regulations, guidances and standards published by ICH, FDA, EMA and other regulatory authorities.
- Designs and manages studies by ensuring proper testing and reporting of stability samples under the most strictest GMP guidelines.
- Assigns retest date/expiry to drug substance, drug product, and reference standard based on analyses of existing data set.
- Proactively trends and evaluates stability data using LIMS.
- Authors stability reports for regulatory submissions.
- Authors stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) testing results.
- Participates in meetings and contributes toward the goals of the CMC team. Contributes to major/critical manufacturing investigations with potential product impact, and leads stability investigations (deviations, OOS, cross-site and cross-functional).
- Acts as a SME for the configuration of lab related software such as LIMS at the site by cross functional interaction with the Site and Global Quality teams.
- BS or MS degree in science (i.e. Analytical Chemistry, Biochemistry, Biology, Chemistry, Organic Chemistry, Pharmaceutical Chemistry, Protein Chemistry) or a similar technical field of study.
- A minimum of 5 years of relevant industry experience, with at least a minimum 2 years of direct experience in stability / formulation of biological and/or small molecule products in the Pharmaceutical industry; 6 years industry experience preferred.
- Knowledge of analytical methods, ICH Guidelines, and strong ability to analyze data.
- Experience on sample management and analytical method validation.
- Good understanding of statistical analysis and interpretation of data. Proficiency with cGMPs and experience with Microsoft Office (Word, Excel, PowerPoint) and statistical softwares are required.
- Strong technical writing skills and communication skills are essential.
- Previous extensive technical experience in Quality Assurance, Quality Control and Manufacturing GMP environments – preferably from the pharmaceutical, medical device, nutrition or dietary supplement industry.
- Demonstrated knowledge of Stability Testing Requirements of new drug substances and products ICH Q1A.
- Knowledge and background in CMC (chemistry, manufacture and controls) is an asset.
- Experience implementing and maintaining quality management systems and programs (ISO9001, GMP, HACCP, ACMPR, and EU GACP, GMP, GDP and GVP requirements) is an asset.