Title:  Manager, Operations

Job Summary

Essential Duties and Responsibilities

• Responsible for the daily, weekly, and long-term manufacturing activities. Manages manufacturing personnel maintaining schedules, ensuring that resources are available, and personnel are adequately trained on processing and safety to execute their activities per established procedures.
• Supervises the manufacture of all products of the plant at the most economical cost consistent with prescribed quality and standards on a timely basis.
• Troubleshoots process, leads/supports closure of area deviations and investigations and ensures implementation of appropriate CAPAs.
• Actively participates/contributes to technology transfer, start-ups, design and implementation of process changes, typically working on cross-functional teams.
• Addresses human resource development opportunities and challenges. Determines staffing needs and organizational structures required to efficiently meet production plans. Develops subordinates to prepare them for future promotion (building bench strength). Actively participates in hiring the best and works to develop an exceptional workforce.
• Maximize capital resources. Responsible for cGMPs. Ensure plant and equipment are maintained to best possible working condition.
• Support customer relations’ efforts by meeting customer standards and delivery dates. Participate in resolving customer problems and reinforce marketing department’s customer relations program.
• Establish methods and means for handling, storage, packaging and delivery of products to prevent damage and deterioration.
• Identify the training needs and schedule required training of all the employees under direct supervision.
• Support Operational Excellence Management and participate on the OpEx initiatives.
• Maximize capital resources and assist in maintaining equipment and facilities in proper working condition. Requests for new capital equipment must be coordinated by working with the appropriate site personnel (i.e. production, engineering, continuous improvement, finance, maintenance and/or plant management) tasked to accomplish this result.
• Consistently promote the plant safety program, lean initiatives, training program and HR policies while holding employees accountable to follow all site policies, practices and procedures while also delivering results.
• Cover for the Site Director when required to do so.
• Participate in customer audits, customer complaint investigations, plant tours, etc. as requested or required.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly and safe workstation and environment at all times.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

Additional Responsibilities

Education

• Bachelor's Degree in a technical discipline to include: Business, Operations, or Engineering. required and
• Master's Degree preferred

Work Experience

• Minimum 8 years 8-10 years of experience. required and
• Experience working with ISO standards, FDA and cGMP required and
• Pharmaceutical manufacturing experience preferred

Preferred Knowledge, Skills and Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Understanding and experience in use of Lean manufacturing principles.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence and process documents.
• Ability to speak effectively before groups and employees in the organization.
• Write monthly progress reports and capital requests.
• Ability to understand mathematical concepts such as probability and statistical inference.
• Ability to problem solve.

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.
• Minimal travel

#LI-TH1