Role Summary
Responsible for the proactive management of the Water Soluble Powders and Tablets manufacturing building in accordance with MNOSHA safety regulations, FDA cGMP regulations, and Local and Federal compliance requirements. A dynamic, hands-on leader with the ability to drive performance through the development of employees via accountability, standards, and continuous improvement; leads by example as a technical expert in powder blending, milling, tablet compression, coating, and packaging processes. An intuitive solutionist to the requirements of the business with a strong understanding of supply chain, operations, and other factors that may cause production delays, while maintaining quality, compliance, and delivery standards through efficient and effective planning, direction, and coordination of all production and maintenance activities within the building.
Key Role Specific Requirements
Management
- Translate company strategy into meaningful plans and actions at the operations level.
- Manages 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.
- Participate in the budget planning process.
- Works 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.
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, workshops, mentorship, etc.
Operations
- Plan, direct, and coordinate all areas of powder and tablet production and related services to produce quality and compliant products, safely and at the most economic cost, to meet on-time customer demand.
- Identify trends in processing times (blending, milling, compression, coating, filling, and packaging) and identify appropriate actions to address and improve operating conditions.
- Provide technical guidance to staff and/or colleagues and anticipate and interpret business needs to identify solutions. Includes approval of technical documentation including investigations, protocols, qualification, validation, etc. as required.
- Interface with external organizations such as the FDA, DEA, Contract Auditors, OSHA, EPA, and others to ensure compliance with current regulations.
- Set and measure team performance/goals, contribute to production scheduling decisions, and work cross-functionally to close deviation investigations and introduce new product SKUs.
- Take a hands-on approach to problem-solve production constraints and/or improve production capacity. Oversee all day-to-day activities within the Water Soluble Powders and Tablets building.
- Lead and support powder handling, blending, tablet press, coating, and packaging equipment modifications and upgrades for automated process efficiency, regulatory compliance, and replacement of obsolescent equipment, controls, and systems.
- Enhance management and operational skills within the production department; provide technical advice to departments within the organization regarding powder blending, compression, coating, filling, and packaging equipment improvement, based on departmental systems used to facilitate the workload.
- Manage the following production lines/departments: Powder Blending & Filling and Tablet Compression, Coating & Packaging (non-sterile, water soluble powders and tablets).
- Apply knowledge of cost accounting principles for a manufacturing environment. Develop cost reduction plans and ensure departments operate within budget.
- Ensure cGMP compliance and attainment of PSQDC (Performance, Safety, Quality, Delivery, Cost) targets.
Continuous Improvement
- 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.
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.
Competencies Required for the Role
COMPLEXITY/STRESS MANAGEMENT/TIME MANAGEMENT - The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly.
CRITICAL THINKING – is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.
FOSTERING COLLABORATION/TEAMWORK - 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.
RESULTS ORIENTED – The ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on the goals, and meeting or exceeding them.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
Other Requirements
Essential
- At least 5 years of pharmaceutical or nutraceutical manufacturing experience, with 3 years of leadership experience directly within solid dose/powder drug product manufacturing (blending, milling, tablet compression, coating, and/or packaging).
- Bachelor's degree in Business Management, Engineering, Chemistry, or equivalent life science field; or significant direct and relevant experience.
- 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.
- Demonstrated leadership and vision in managing staff groups and major projects or initiatives.
- Demonstrated commitment to high professional ethical standards and a diverse workplace.
- Excellent people management skills.
- Strong command of the English language; written and verbal.
Desirable
- Degree in Manufacturing Technology, Engineering, or related field.
- 2–3 years of Continuous Improvement experience – Green Belt or Black Belt Certification a plus.
Prior experience with water soluble powder and/or tablet manufacturing equipment (e.g., ribbon blenders, fluid bed processors, tablet presses, coating pans).
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What We Offer
- Health Insurance (medical, dental, vision)
- 401(k) plan for retirement savings
- Paid time off (vacation, sick leave, holidays)
- Life insurance
- Employee assistance program
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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More Info at www.bimedacareers.com
Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
