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Director of Operations

Req # JR - 030798 Location Bloomington, Indiana Job Category Manufacturing Date posted 11/30/2020

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Summary:

The Operations Director is responsible for the development, coordination and execution of clinical and commercial manufacturing for syringe, vial and cartridge filling and packaging activities.  This position oversees a function of approximately 300 employees, including hourly production operators, group leaders, supervisors, manufacturing warehouse operations and managers; and is responsible for the strategic planning of the department.  This position reports to the Plant Manager.

Responsible for all aspects of production within area of responsibility with a focus on optimizing safety, quality, service and cost.  Directs all phases of programs from inception through completion. Responsible for the cost, schedule and technical performance of company programs or subsystems of major programs (e.g. lean, VIPs). Coordinates the preparation of proposals, business plans, proposal work statements and specifications, operating budgets and financial terms/conditions of contract.  Establishes design concepts, criteria and engineering efforts for product research, development, integration and test. Establishes milestones and monitors adherence to master plans and schedules, identifies program problems and resolves, such as allocation of resources or changing contractual specifications. Directs the work of employees assigned to the program from technical, manufacturing and administrative areas and performs all duties with a focus on optimizing safety, quality, service and cost. 

Essential Duties and Responsibilities:

• Responsible for the outgoing quality, safety and efficacy of all finished products and compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that may apply.

• Develops and proposes strategies from the data gathered to support the manufacturing operating system.  Contributes to and drive plant-wide strategy as a member of the plant leadership team.

• Ensures budgets, schedules, and performance requirements are met.

• Improves product quality and cost and reduce customer complaints through a proactive program that includes interaction with internal and external suppliers. Utilizes collected data from customers to enhance perceived product quality.

• Responsible for resolving complex problems and using sound judgment where analysis of situations or data requires an in-depth evaluation of multiple factors.

• Regularly interacts with senior leaders on matters concerning functional areas and/or service levels.

• Create an alliance with major support functions to develop the processes (Quality, Technical Services, Engineering - Maintenance, Supply Chain, Program Management, etc) to meet customer expectations.

• Interview, hire, coach, motivate, develop, recognize and manage performance of direct reports.  Provides regular feedback to all direct reports.  Sets performance objectives, support development plans and monitor progress.

• Drives plant-wide strategic plan programs and activities.

• May represent Manufacturing in new product designs to assure design for manufacturing, testability and reparability.

• Budget development and maintenance to meet business needs

• Partner with Human Resources and working with subordinates create a process to consistently enforce standards, timely recognition of good performance, proper training, and professional development of manufacturing leaders

• Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens.  

• Participates as subject matter expert in audits.

Qualifications:

• Proven track record of interpersonal and leadership skills with ability to interface well with other departments leaders and/or personnel and lead effectively and efficiently in a team environment.

• In-depth process knowledge of related manufacturing equipment and processes.

• Ability to manage multiple priorities in a manufacturing plant setting.

• Ability to analyze and interpret scientific, and statistical data.  Apply data analysis to problem-solve and make strategic decisions.

• Strong professional writing skills and ability to prepare technical reports.  Ability to clearly articulate information during regulatory/client inspections.

• Ability to understand GMPs and other applicable regulatory guidelines and ability to manage audit-related activities.

• Strong assessment and troubleshooting skills.

• Ability to respond to detailed inquiries and present information to groups and senior leaders.

• Ability to supervise multiple groups/shifts, if applicable.

• Computer proficiency in Microsoft Office and ability to use enterprise software.

• Ability to collect and analyze data and information to determine paths for process improvement and potential root cause

• Ability to respond to detailed inquiries and present information to groups and senior leaders.

• Demonstrated critical thinking and problem-solving skills.

• Working knowledge of manufacturing business acumen.

• Green or Black Belt certification preferred.

• Proven track record of meeting budgets, schedules and performance requirements and holding other accountable to the same.

Safety/Physical Requirements:

• Duties may require overtime work, including nights and weekends

• Use of hands and fingers to manipulate office equipment is required

• Position requires sitting for long hours but may involve walking or standing for periods of time. 

• Ability to meet Grade A/B gowning requirements.

Education and/or Experience:

• Bachelor's degree required

• MBA preferred

• Must have knowledge of GMPs and worldwide regulatory agency guidelines

• 10 years manufacturing/operations experience including 5 years of leading leaders.

• Lean Manufacturing experience required (i.e. value stream mapping, 6S, leading kaizen events to drive positive change on the floor, problem-solving methodology and teaching people to think)

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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  • Manufacturing, Bloomington, Indiana, United StatesRemove

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