Integra LifeSciences
Director, Manufacturing
Integra LifeSciences, Plainsboro, New Jersey, United States,
Integra LifeSciences Director, Manufacturing Plainsboro, New Jersey Apply Now
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Director, Manufacturing is a key member of the plant leadership team responsible for leading the overall manufacturing operations for Integra’s Collagen Manufacturing Center (CMC), working within FDA medical device regulations and ISO Standards. Accountable for strategic thinking, and a deep understanding of manufacturing operations. Providing overall direction for manufacturing operations driving high performance in safety, quality, delivery and cost objectives while remaining focused on employee engagement. Leading change in an organization driven by continuous improvement and lean mindset to reduce waste and maximize operational efficiency. SUPERVISION RECEIVED Under the supervision of the Plant Manager of the CMC Plainsboro, NJ site. SUPERVISION EXERCISED Manufacturing and Training ESSENTIAL DUTIES AND RESPONSIBILITIES Oversees, directs and manages a group of manufacturing managers engaged in production operations to the assigned department. Receives, reviews and manages the production orders and schedules logistics to ascertain product data, such as types, quantities, and specifications of products and scheduled delivery dates in order to plan department operations. Work close with the Managers, Supervisors and Production planning to drive strategies oriented to the production operations plans, establishing priorities and sequences for manufacturing products, utilizing knowledge of production processes and methods, machine and equipment capabilities and human resource requirements. Drive a culture of continuous improvement; including but not limited to structured problem solving with root cause analysis, waste reduction, efficiency improvements. Facilitate teamwork and cooperation with a focus on developing a LEAN culture with the ultimate goal of high levels of employee engagement and customer satisfaction. Prepares operational schedules and coordinates manufacturing activities to ensure production and quality of products meets specifications. Champion employee talent development through active management and coaching. Strong collaboration with peer plant leadership team members to resolve issues and solve problems. Receives production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays. Evaluates performance on a timely basis and recommends personnel actions, such as promotions, transfer, discharge, or disciplinary measures. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Informs and maintains required communication with management peers related to quality issues related to manufacturing operations, deviations occurring from existing standards, deficiencies and accomplish cost reductions and company goals. Encourages workers support to the department efficiency and accomplishment of production plan and company goals. Ensures through behavior and actions that workers adherence to GMP, company policies, safety practices, and Clean Room Rules, and Gowning Practices. Review and approve investigations, participate of meetings such as Validation Review Board, Change Control, Material Qualification programs, Weekly Site performance review, Complaints Review Board among others. Responsible for overall key performance indicators of the manufacturing area. Manage other duties as assigned. DESIRED MINIMUM QUALIFICATIONS Bachelor’s Degree in Engineering, Science or other relevant field. 15 years professional experience is preferred in a medical device or pharmaceutical manufacturing environment including five years in a management position. Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude. Strong interpersonal and communication skills. Demonstrated knowledge of FDA regulations and other National and International regulations and standards. Demonstrated computer skills. Strong background in continuous improvement and problem solving. Solid strategic thinking skills to challenge status quo. INTEGRA LEADERSHIP CAPABILITIES As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities. Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole. Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business. Drive Performance: Leaders with this capability drive performance and accountability through others and self. Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams. TOOLS AND EQUIPMENT USED Computers, specialized software for complaint reporting, general office equipment including, printers, copiers, scanners, and fax machines. PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed. ADVERSE WORKING CONDITIONS There are no anticipated adverse working conditions associated with this position. SELECTION GUIDELINES Formal application, rating of education and experience; oral interview and reference check; job related tests may be required. DISCLAIMER The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Director, Manufacturing is a key member of the plant leadership team responsible for leading the overall manufacturing operations for Integra’s Collagen Manufacturing Center (CMC), working within FDA medical device regulations and ISO Standards. Accountable for strategic thinking, and a deep understanding of manufacturing operations. Providing overall direction for manufacturing operations driving high performance in safety, quality, delivery and cost objectives while remaining focused on employee engagement. Leading change in an organization driven by continuous improvement and lean mindset to reduce waste and maximize operational efficiency. SUPERVISION RECEIVED Under the supervision of the Plant Manager of the CMC Plainsboro, NJ site. SUPERVISION EXERCISED Manufacturing and Training ESSENTIAL DUTIES AND RESPONSIBILITIES Oversees, directs and manages a group of manufacturing managers engaged in production operations to the assigned department. Receives, reviews and manages the production orders and schedules logistics to ascertain product data, such as types, quantities, and specifications of products and scheduled delivery dates in order to plan department operations. Work close with the Managers, Supervisors and Production planning to drive strategies oriented to the production operations plans, establishing priorities and sequences for manufacturing products, utilizing knowledge of production processes and methods, machine and equipment capabilities and human resource requirements. Drive a culture of continuous improvement; including but not limited to structured problem solving with root cause analysis, waste reduction, efficiency improvements. Facilitate teamwork and cooperation with a focus on developing a LEAN culture with the ultimate goal of high levels of employee engagement and customer satisfaction. Prepares operational schedules and coordinates manufacturing activities to ensure production and quality of products meets specifications. Champion employee talent development through active management and coaching. Strong collaboration with peer plant leadership team members to resolve issues and solve problems. Receives production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays. Evaluates performance on a timely basis and recommends personnel actions, such as promotions, transfer, discharge, or disciplinary measures. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Informs and maintains required communication with management peers related to quality issues related to manufacturing operations, deviations occurring from existing standards, deficiencies and accomplish cost reductions and company goals. Encourages workers support to the department efficiency and accomplishment of production plan and company goals. Ensures through behavior and actions that workers adherence to GMP, company policies, safety practices, and Clean Room Rules, and Gowning Practices. Review and approve investigations, participate of meetings such as Validation Review Board, Change Control, Material Qualification programs, Weekly Site performance review, Complaints Review Board among others. Responsible for overall key performance indicators of the manufacturing area. Manage other duties as assigned. DESIRED MINIMUM QUALIFICATIONS Bachelor’s Degree in Engineering, Science or other relevant field. 15 years professional experience is preferred in a medical device or pharmaceutical manufacturing environment including five years in a management position. Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude. Strong interpersonal and communication skills. Demonstrated knowledge of FDA regulations and other National and International regulations and standards. Demonstrated computer skills. Strong background in continuous improvement and problem solving. Solid strategic thinking skills to challenge status quo. INTEGRA LEADERSHIP CAPABILITIES As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities. Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole. Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business. Drive Performance: Leaders with this capability drive performance and accountability through others and self. Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams. TOOLS AND EQUIPMENT USED Computers, specialized software for complaint reporting, general office equipment including, printers, copiers, scanners, and fax machines. PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed. ADVERSE WORKING CONDITIONS There are no anticipated adverse working conditions associated with this position. SELECTION GUIDELINES Formal application, rating of education and experience; oral interview and reference check; job related tests may be required. DISCLAIMER The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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