Reporting to the Sr. VP Operations, the Operations Manager is responsible for the proactive management of a manufacturing facility in accordance with safety regulations, USDA, and other applicable regulatory compliance. A dynamic hands-on leader with the ability to drive performance by the development of employees through accountability, standards, continuous improvement; leads by example as a technical expert in the Bacterin and virus vaccine production processes and facilities. Intuitive solutionist to the requirements of the business with a good understanding of supply chain, operations and/or any other factors that may result in productions delays, while maintaining quality, compliance, and standards of delivery; through efficient and effective, planning, directing and co-ordination of all production activities

Responsibilities

Operations Management

• Lead by example and proactively communicate and collaborate with internal staff, site and company colleagues, and external stakeholders to drive results. 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 production needs and execute actions including, but not limited to, process management, staffing, equipment, and training.
• Translate company strategy into meaningful plans and actions at the operations level. 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.
• Ensure proper communication is maintained with internal and external customers and regulatory organizations such as the USDA, US - FDA, Contract Auditors, 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. Observe and align operations in all departments to acquire knowledge of methods, procedures and standards as related to departmental duties.
• 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.
• Attracts, retains, and develops the management and operation skills within the production, production support and maintenance departments.
• Leads the site budget planning process. Work with the production budget and strive for cost management and improvements. Develops cost reduction plans and ensure departments operates within budget.
• Ensure compliance & attainment of PSQDC (Performance, Safety, Quality, Delivery, Cost) targets. 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.

People, Employee Development and Succession Planning

• Build and sustain empathy and trust by actively listening, understanding, coaching, and supporting employees and team members.
• Translates broad strategies into specific objectives and action plans. Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• 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 Regulatory training are current and that all employees are compliant.
• Develop employees through daily learning, training, mentorship, etc. Drives a sense of purpose or vision for self, group, or team.
• Collaborates and engages with multiple functional departments such as Commercial, Quality, Supply Chain Management, Regulatory Affairs, Finance and HR to develop and maintain processes that business requirements and customer expectations.

Continuous Improvement

• Make Continuous Improvement a priority in the day-to-day life of the production system and management.
• 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.

Required Competencies

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.

DEALING WITH AMBIGUITY– The ability to be comfortable with change and uncertainty. The ability to deal with fuzzy problems with limited data and with no clear solutions. The ability to juggle several projects or to not bring closure to one project because of business changing needs.

ENGAGEMENT, DRIVE AND EMPOWERMENT - The ability to convey confidence in employee’s ability to be successful, especially at challenging new tasks; delegating significant responsibility and authority to engage employees; allowing employees freedom to decide how they will accomplish their goals and resolve issues.

Qualifications

Essential:

• 7 -10 years of bio-pharmaceutical manufacturing/product development experience, with 3 -5 years of leadership experience directly within drug product manufacturing that includes bacterin and virus production environments.
• Bachelor of Science in Engineering or Life Sciences. Masters in Life Science and/or MBA preferred.
• Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making. Ability to leverage one’s influence; given situation and achieve the appropriate level of impact; given the expected outcome.
• Knowledge on cost accounting principles for a manufacturing environment. Ability to perform departmental capacity analysis to recommend short and long-term strategies.
• Strong working understanding of bacterin and virus manufacturing with expertise in USDA, and US FDA regulations.
• Working knowledge of the principles of Continuous Improvement, Lean Manufacturing and Operations Excellence.
• Strong communications skills. Ability to communicate effectively and efficiently within every level of an organization, both internal and external to Bimeda.
• Self-motivated with a good understanding of the “big picture” and utilizes own initiative. Aligns personal, team and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them.
• Ability to challenge and debate issues of importance to the organization. Open to direction with a collaborative style of work and a commitment to a job well done.
• 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. Excellent people leader with transformation and change management experience.

About Bimeda

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 optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers 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 commercialization 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.

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