Key Role Specific Requirements
- Plan, direct and coordinate all areas of production and related services to produce quality and compliant products, safely at the most economic costs to meet on time customer demand.
- Identify trends in processing times and identify appropriate actions to address; and improve operating conditions.
- Provide technical guidance to staff and/or colleagues as well as anticipates and interprets the business needs to identify solutions. Includes approval of technical documentation including investigation, protocols, qualification, validation etc. as required.
- Interface with external organizations such as the Health Canada, US - FDA, Contract Auditors, MOL-OHSA and others to ensure compliance with current regulations. Includes responding to corrective actions and/or observations as required.
- Lead manufacturing 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.
- Set and measures team performance/goals, contribute to production scheduling decisions, and work cross-functionally to close deviation investigations and introduce new product SKUs.
- Hand-on approach to problem solve production constraints and/or improve production capacity. Oversees all day-to-day activities in the manufacturing departments.
- Lead and support filling and packaging equipment modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolescent equipment, controls and systems.
- Enhance the management and operation skills within the production department; provide technical advice to departments within the organization regarding compounding, filling and packaging equipment improvement based upon the departmental systems used to facilitate the workload.
- Knowledge on cost accounting principles for a manufacturing environment. Develops cost reduction plans and ensure departments operates within budget.
- Ensure cGMP compliance & attainment of PSQDC (Performance, Safety, Quality, Delivery, Cost) targets
- Translate company strategy into meaningful plans and actions at the operations level.
- Manage and evaluate daily, weekly and monthly KPI information to identify bottlenecks and enables and executes actions to problem solve and remove obstacles to ensure smooth flow of production.
- Lead by example and proactively communicate and collaborate with internal staff, colleagues, the union and external stakeholders to drive results.
- Participate in the budget planning process.
- Work with the production budget and strive for cost management and improvements.
- Ensure proper communication is maintained with internal and external customers.
- Observe and align operations in all departments to acquire knowledge of methods, procedures and standards as related to departmental duties.
- Identify production needs and execute actions including, but not limited to, process management, staffing, equipment, and training.
- Make Continuous Improvement a priority in the day to day life of the production system and management.
- Member of the Joint Health & Safety Committee.
Employee Development and Succession Planning
- Build and sustain empathy and trust by actively listening, understanding, coaching and supporting employees and team members.
- Assess existing talent to determine if skills/competencies are appropriate for current roles and future goals.
- Set performance goals and objectives with direct reports.
- Ensure SOP, Safety and CGMP training are current and that all employees a compliant.
- Develop employees through daily learning, training, mentorship, etc.
- Support CI project teams by providing adequate time for activities to facilitate process improvements.
- Encourage and mentor CI Leaders to educate and empower a CI mindset throughout the production operations.
- Participate as a role model in establishing a CI culture with responsibility to translate onto the manufacturing floor.
- 5 – 7 years of bio-pharmaceutical experience, with 3 years of leadership experience directly within drug product manufacturing that includes aseptic and sterile filling environments
- Bachelor of Science in Engineering or Life Sciences
- Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making
- Ability to perform departmental capacity analysis to recommend short and long-term strategies.
- Strong general understanding of parenteral drug manufacturing with expertise in Health Canada, US FDA and EU regulations.
- Demonstrated leadership and vision in managing staff groups and major projects or initiatives. A demonstrated commitment to high professional ethical standards and a diverse workplace. Excels at operating in a fast pace environment. Excellent people manager with transformation and change management experience.
- Open to direction with a collaborative style of work and a commitment to a job well done.
- Ability to challenge and debate issues of importance to the organization.
- Highly skilled in leadership, strategic thinking, analytical ability, with effective people; change; and transformation management skills.
- Self-motivated with a good understanding of the “big picture” and utilizes own initiative.
- Successful Team builder whether leading or a part of a team.
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved
- Drives a sense of purpose or vision for self, group or team
- Translates broad strategies into specific objectives and action plans
- Working knowledge of the principles of Continuous Improvement, Lean Manufacturing and Operations Excellence.
- Makes critical choices that support strategy and ultimately the end customers
- Aligns personal, team and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them
- Provides direction to others that clarifies their expectations and role
- Collaborates and engages with multiple functional departments such as Quality Assurance, Quality Control, Engineering Supply Chain and Finance to develop and maintain processes that meet cGMP and business requirements.
- Experience in labour relations and in the management of unionized employees.
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