Position Title Techno. Transfer Specialist

Job ID	133454BR
Division	Sandoz
Business Unit	Sandoz - Technical Operations
Country	Canada
Work Location	Montreal South Shore – Boucherville
Company/Legal Entity	Sandoz Canada
Functional Area	Production
Job Type	Full Time
Employment Type	Regular
Job Description	Choosing Sandoz, a healthy decision. Located in Boucherville, Québec and counting over 950 employees, Sandoz Canada is one of Canada’s fastest growing pharmaceutical manufacturers. Our plant in Boucherville is one of the largest sterile pharmaceutical manufacturing plants in Canada. Our vision We will be the main provider of high quality, affordable medicines helping secure long-term access to healthcare for people around the world. We will lead our industry, outperforming the market. We will bring the care and passion our employees have for their work to our customers, patients and communities. Join the Sandoz Canada Team! Due to significant investments in Boucherville’s facilities, several new positions are currently opened. Recognized for your leadership and expertise, your commitment to quality and customers and also you are confortable and challenged in a fast paced environment, come join our team. We are currently looking for a Techno. Transfer Specialist. Reporting to the Process Optimization Manager, the Techo. Transfer Specialist will ensure the production of regulatory batches for new products and identify ways to optimize their commercial manufacture using QRA, QbD, DoE and other tools. Summary of tasks: Monitor scale-up activities. Ensure the robustness of existing procedures and carry out risk assessments of procedures using FMECA, PHA and EHA tools. Identify CPPs and CMAs before the procedure is validated. Track batches in CPV. Manage the various stages required for the introduction of new products; Inform the production department of the procedure’s specifics. In tandem with the Development Centre, ensure the production of batches; Ensure that all production documents required for submission are completed and non-compliances are targeted, and take part in investigations during development; Identify and produce reports on critical stages; Draft MPTRs (manufacturing process transfer reports); Assess the risks of the procedure in view of scale-up activities for commercial batches (FMECA or PHA and EHA), determine CPPs (critical process parameters) and validate the procedure; Ensure regulatory batch post-mortem recommendations are implemented; Analyze the procedure’s criticality (FMECA) for the procedure’s validation; Monitor the production of batches; Optimize current procedures; Proceed with scale-up activities; Make engineering batches, as needed; Develop QRAs (quality risk assessments) for products and determine CPs for future validation batches; Define the performance of procedures using statistical calculations such as Cpk and Ppk; Track batches included in the CPV (continued process verification) program to ensure procedures are reliable, stable and reproducible. Ensure the master validation plan is carried out and procedures are continuously checked. Identify changes for continuous improvement of procedures; Be aware of requests from other departments; e.g. to investigate issues encountered in production and/or filling, stability or R&D; Be aware of advances in pharmaceutical production and transfer this knowledge to technical operations.
Minimum requirements	Bachelor's degree in biochemistry, chemical engineering, chemistry, or pharmaceutical development French and English Eight (8) to twelve (12) years; Experience in the pharmaceutical industry (production, development), technology transfer, development of drugs, formulation At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.                                                           Apply Only candidates selected for an interview will be contacted.