Location: Cambridge, ON
Compensation: $110K-$130K (Wanting someone more experienced so willing to pay up to $150K for someone really amazing). 10% bonus, pension, 4 weeks vacation
Support the development and leads the implementation of the site’s strategic 5-year business plan, budget, long-range goals and vision for site manufacturing operations.
Maintains buildings, infrastructure, manufacturing lines and machinery/equipment in an operational state to OpEx standards, including planned maintenance, unplanned/emergency maintenance and execution of routine work orders. Ensuring a Customer First culture.
Drives a culture of high performance where everyone is committed to and accountable for delivery of performance goals and site KPIs at Tier 3 and 4. Leads by example and achieves results through direct reports by communicating job performance expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching and reviewing performance results; providing training and skill development opportunities for growth and improved performance.
Utilizes best practice knowledge to adapt and implement new methods and lean-continuous improvement practices for manufacturing production improvement through the examination of equipment, processes, operations and packaging. Maintains and publishes KPI’s that measure success of objectives and drives continuous improvement.
Ensures a culture of Right first time/Safety First and that all manufacturing operations are conducted in compliance with Health & Safety regulations, cGMP, and company policies in a highly regulated sterile manufacturing environment.
Drives effective coordination with Quality Assurance and Quality Control to assure that raw materials / final products are tested and released to accommodate the production schedule and sales needs.
Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analysing variances; initiating corrective actions.
Communicates issues, risks and discrepancies to senior management and offers solutions to mitigate/solve problems.
Ensures the front-line management are driving culture change based on the organisations needs and objectives, ensure the operations are structured to effectively deliver the business.
Ensures quality of investigations regarding batch discrepancies and out-of-specification events to ensure corrective action and non-recurrence and maintains the facility in a state of compliance.
Ensures a sitewide approach to hosting facility audits by customers, FDA and EU including responding to corrective actions and /or observations as required.
As a key stakeholder in NPI, CAPEX projects the plant manager is responsible to ensuring what is delivered to Operations meets the operational requirements.
Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels of the organization to achieve results
10 years Pharmaceutical Manufacturing Experience
BSc Engineering/ Life sciences/ Bio Medical/ Bio Chemical
Must possess a strong general understanding of liquid and solid dose drug manufacturing with expertise in both Health Canada, US FDA and EU regulations
Must possess working knowledge of the principles of Continuous Improvement, Lean Manufacturing and Operational Excellence
Has managed 80-100 employees or more
5 years of experience in sterile manufacturing
Understanding of Parenteral Drug Manufacturing