OverviewSANDOZ Formulation & Process Specialist (18 months) Temporary in Montréal, QC
Branch Montréal QC CA
Formulation & Process Specialist (18 months)
Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country….
Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country. Our vision: to become the main provider of high quality, affordable medicines and help secure long-term access to healthcare for people around the world. If you are results oriented and recognized for your leadership, expertise, commitment to quality and customers, come join our team!
We are currently looking for a Formulation & Process Specialist:
Reporting to the Formulation & Process Manager, the Specialist, is primarily responsible for assessing and scaling up manufacturing processes. The work includes developing project formulas and studies to determine the critical parameters that will affect each process.
Summary of tasks:
Issue protocols and monitor the production of batches used to define the critical parameters of the processes. Analyze laboratory batch results with a view to submitting a report, which is then used to draft the DSR. Assess the equipment and systems needed to manufacture submission batches in accordance with specifications and regulations;
Coordinate the transfer of manufacturing processes to the external site. Draft the transfer protocol and act as technical resource person at the site where the regulatory/clinical batches are produced;
Help solve technical and process-related problems encountered when scaling up production;
Analyze regulatory batch results so as to recommend changes to the manufacturing process to support commercial scale-up;
Contribute to the advancement of the development centre by incorporating research on new equipment and manufacturing processes.
Bachelor of Science degree or equivalent;
Three (3) to five (5) years’ experience in a similar role;
Knowledge of Good Laboratory Practices and laboratory activities;
Knowledge of formulation equipment;
Knowledge of USP, EP, BP, etc. monographs;
Specific knowledge of international regulations (ICH, FDA, Canadian and European regulatory agencies);
Fluency in French and English, both written and spoken;
Sound judgment, strong analytical and problem-solving skills;
Ability to multitask and meet deadlines in a fast-paced environment;
Attention to detail, pride in a job well done and commitment to customer satisfaction.
At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.
Only candidates selected for an interview will be contacted.
Employment Type: Temporary
Location: Montreal, QC, CA
Posted on: 2015-12-04