A collaborative performance orientated individual with the ability to implement, lead change and people management initiatives within an established unionized workforce. An individual that maintains a broad, flexible and strategic view of the manufacturing function and provides strategic/tactical direction to all related manufacturing functions. A leader who will provide visionary leadership, innovation and acts as a change agent who will drive growth. Reporting directly to the Plant Manager will be the Production Manager, Validation Manager and Facility Maintenance Manager.
Key Role Specific Requirements
- Utilize best practice knowledge to adapt and implement new methods and lean-continuous improvement practices for the site.
- Examination of equipment, processes, operations and packaging
- Maintain and publish KPI’s that measure success of objectives and drives continuous improvement.
- Responsible for ensuring consistent product delivery.
- Resolve complex commercial manufacturing issues
Performance and Leadership
- Lead by example and achieve results through direct reports by communicating job performance expectations & company vision.
- Contribute to the corporate vision by establishing the policies and infrastructure decisions that ensure linkage to the business strategy.
- Excellent collaborator and proven technical leader with experience in a cGMP pharmaceutical drug product manufacturing environment
- Drive 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.
- Lead cultural and organizational change, implement operational excellence and lean manufacturing for continuous improvement of competitiveness and financial performance.
- Establish individual goals in line with corporate/departmental objectives, coaching and reviewing performance results.
- Accomplish financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analysing variances; initiating corrective actions.
- Support the development and lead the implementation of the site’s strategic 5-year business plan, budget, long-range goals and vision for site manufacturing operations.
- Ensure appropriate resources are available to meet the Company’s continued requirements for growth.
- Accountable for product cost drivers, overall cost ownership, risk management and ongoing cost improvement for all products.
Health, Safety and Compliance
- Ensure that GMP standards are applied such that the manufacturing facility is always prepared for regulatory and client inspections.
- Ensure 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.
- Maintain 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.
- Ensure 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.
- As a key stakeholder in New Product Introduction, CAPEX projects the Plant Manager is responsible to ensuring what is delivered to Operations meets the operational requirements.
- Ensure a sitewide approach to hosting facility audits by customers, FDA and EU including responding to corrective actions and /or observations as required.
- Communicate issues, risks and discrepancies to senior management and offer 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.
- 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
- A minimum of 10-15 years of relevant experience within a highly regulated manufacturing facility specializing in solid and liquid dose manufacturing in an aseptic and sterile manufacturing environment. A minimum of 10 years of leadership on a manufacturing floor.
- Must possess a strong general understanding of liquid and solid dose drug manufacturing with expertise in both Health Canada, US FDA and EU regulations
- Technical qualifications as defined in Health Canada guidelines, including a university degree in a discipline relevant to the requirements of the job.
- Demonstrated experience in leading and managing a team of technical and non-technical personnel to achieve manufacturing objectives.
- Experience driving both continuous improvement and quality improvement initiatives
- Established leadership qualities to successfully interface and communicate with all levels of the organization.
- Experience leading within cross functional environments, driving decisions regarding overall manufacturing and supply chain priorities
- Strong general understanding of parenteral drug manufacturing with expertise in Health Canada, US FDA and EU regulations
- A strong quality orientation to enable collaboration with Quality personnel.
- Experience in execution of capital projects in a manufacturing setting.
- Sound knowledge of Good Production Practices and Good Manufacturing Practice Guidelines from Health Canada.
- Excellent planning and organizational skills.
- Exceptional communication and leaderships skills.
- Excellent ability to manage multiple priorities and work under pressure.
- Strong organizational, problem solving and analytical skills.
- Ability to work in a fast-paced and changing environment.
- Must possess working knowledge of the principles of Continuous Improvement, Lean Manufacturing and Operational Excellence
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. The job posting is available in an accessible format upon request by contacting the Human Resources Manager
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com