Summary/ Objective

The Production Manager, assures quality and manufacturing processes in conformance with SOPs, WIs, and cGMPs. Authority to
make decisions related to quality, efficient production, job assignment, safety, and discipline. Coordination of all production
activities. Leads by example and positive attitude and provides direction and training to employees.

Essential Functions

MANAGEMENT OF PRODUCTION OUTPUT

• Ensures timely completion of production orders including: scheduling of equipment, maintaining proper quantity of preform stock, processing aids, employee equipment, and any other pertinent tasks, as needed.
• Coaches and supports the development of Production Supervisors
• Ensures proper procedures and training are appropriate according to ISO and cGMP standards; investigates procedural failures including IT related issues, revises and/or drafts SOPs and Work Instructions as required.

LEADING AND MANAGING THE PRODUCTION DEPARTMENT

• Hires, trains, develops, and appraises department staff effectively
• Effective management of department personnel: coaching, feedback, professional development and performance management
• Ensures department staff work aligns with business needs and strategic goals
• Ensures department staff are trained on procedures in compliance with their training plan
• Consults with Human Resources as appropriate
• Works with colleagues locally, and globally as needed to provide support and analysis of US and/or company wide production issues
• Assigns and monitors progress toward completion of department projects
• Other duties as assigned

ENSURES SAFETY COMPLIANCE OF DEPARTMENT

• Ensures that incumbent’s department complies with all safety rules and procedures, gowning requirements, as well as good housekeeping within the plant, in accordance with SOPs, work instructions, and cGMPs
• Works with Environmental, Health and Safety (EHS) Manager to ensure safety and environmental compliance of the Middletown, Delaware facilities with federal, state, and local government regulations

ENSURES QUALITY STANDARDS OF PRODUCTION

• Manages the department's CAPA processing, validation, process improvements and establishes the department direction for future projects
• Addresses customer complaints by developing short-term and long-term plans to prevent reocurring issues
• Reviews and recommends new or enhanced procedures and/or processes to maximize efficiency and to continuously improve quality of product produced
• Establishes procedures consistent with Quality standards
• Creates work instructions that satisfy Quality system requirements

Your Profile

• MS in Engineering or MBA preferred, or equivalent technical knowledge with 5-10 years experience in manufacturing environment
• Experience in a manufacturing environment with increasing supervisory and departmental management responsibilities
• Experience managing in a unionized environment
• Experience in a GMP environment
• Experience in a Chemical based manufacturing facility preferred
• Excellent PC skills including MS Office Word, Excel and Access
• Prior experience with SAP or similar ERP system; experience using Manufacturing Execution Systems and/or SCADA preferred
• Experience working in environment where Continuous Improvement initiatives are common