Manager, Filling and Packaging Promega
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JOB OBJECTIVE: A hands on management role that leads the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times. Ensures the effective use of materials, equipment and employees in producing quality products. Formulates and recommends manufacturing policies, procedures and programs. Areas of responsibility include manual and automated dispensing, lyophilization, labeling and all kit assembly using secondary and tertiary packaging.
Provide leadership and management, of the roles and activities of all assigned manufacturing personnel in order to ensure the successful, effective, efficient and safe filling and packaging of products. Work with Engineering and Bulk Production to develop and apply continuous Improvement strategies. Responsible for achievement of key performance metrics. Work with Quality to ensure cGMP compliance.
1. Provide technical and managerial leadership in all areas of responsibility.
? Effectively manages employee relations including hiring, discipline, rewards and recognition, and effective human capital resource allocation.
? Coach, advise, provide direction, educate, motivate, and oversee teams in the performance improvement process to increase manufacturing effectiveness across filling, lyophilization and packaging operations.
? Set the appropriate priorities for the department and provide leadership for daily direction setting and problem solving in order to maximize results.
? Develop departmental goals that support the strategic goals of Operations and the entire company.
2. Ensures compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines.
3. Support new product design, and change from design phase through product launch.
4. Benchmarking Best Practice companies for improvements to filling, lyophilization and packaging operations.
5. Support groups in the specification, installation, start-up, validation and maintenance of production equipment.
6. Perform strategic planning, budgeting and operations analyses within all areas of responsibility. Manage financial performance with budget controls, variance management, and capital management.
7. Maintain ongoing analysis of key issues, projects, and objectives, and provide regular written reports that include metrics to summarize the status and trends of key operational parameters.
8. Coordinate activities and resolution of complex issues and potential problems related to manufacturing and inventory.
9. Ensures that all Manufacturing and Packaging procedures are kept up to date, and reflect current regulatory requirements.
10. Aggressively look for areas of manufacturing process improvement which may include additional capital investment, procedural revision or staffing changes.
11. Collaborate with internal lyophilization expertise in the development of new lyophilized products and processing of custom lyophilized products.
12. Will understand and comply with all elements of the Promega Quality System outlined for the position.
1. Bachelor of Science in a technical field such as engineering, microbiology, etc., with experience in business management OR Bachelors of Business with equivalent experience in filling and packaging.
2. Minimum ten years manufacturing supervision/management experience in filling and packaging (pharmaceutical, specialty Biochemicals, etc.).
3. Minimum five years? experience in filling and or packaging in a regulated environment preferably Invitro Diagnostics or parenteral pharmaceutical.
4. Minimum five years project management experience in a technical area within a cross-functional team environment.
5. Must possess solid computer skills to include ERP systems (SAP) and Microsoft Suite (Word, Excel, PowerPoint, etc.).
6. Strong organizational and communication skills and a demonstrated ability and desire to share experience and knowledge with staff.
7. Experienced in managing controlled environments and/or clean room operations.
1. Experience with continuous improvement methods such as Six Sigma, Lean Manufacturing, etc.
2. Experience with Statistical Process Control and statistical quality.
3. Experience with product formulation.
4. Experience with operation of automated dispensing and packaging lines.
5. Experience with operation and maintenance of lyophilizers.
1. Must be able to perform inspections of equipment and operations for cleanliness and safety.
2. Must have the ability to use computer equipment for extended periods of time.
3. Must be able to travel up to 10% of the time.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer
Madison, Wisconsin, United States
||2800 Woods Hollow Road |
Madison, WI 53711
THIS JOB HAS EXPIRED