Production Manager

Bimeda•Le Sueur, MN

11d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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).

Responsibilities

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.
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.
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.
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.