GM//Plant Manager / Pharma / Manufacturing / Philadelphia, PA.
SUMMARY:
This manager will be responsible for the planning, and execution of the production goals set by
senior management, including batch manufacturing, and packaging. The manager will oversee
all production operations in the plant.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Direct authority in the Manufacturing, Packaging and Validation operations.
• Establish cGMP training programs for Manufacturing, Packaging and Validation operations.
• Establish tooling maintenance program.
• Review existing SOP'S and revise if necessary.
• Implementation of new SOP'S
• Assure that Manufacturing, Packaging and Validation operationsare staffed properly.
• Interface with other departments (QC, Maintenance, Purchasing, and Product
Development).
• Produce weekly production schedules for Manufacturing and Packaging
Departments with the assistance of their respective supervisors and the
Schedule Coordinator.
• Create time studies which will include direct and indirect labor for all products
produced.
• Direct involvement with outside technical representatives.
• Direct involvement with outside suppliers/vendors concerning equipment and
supplies.
• Assure both Manufacturing and Packaging Preventive Maintenance Programs
are implemented.
• Assure that Manufacturing and Packaging have the equipment and supplies
needed to operate without any disruption.
• Responsible for hiring and terminating Manufacturing, Packaging and Validation operations personnel.
• Responsible for annual reviews of Manufacturing and Packaging personnel.
• Based on Sales Department's Forecasts and desired inventory build-up, create
the Annual Production Plan, in quarterly installments, and update the production
plan periodically (monthly, or at least quarterly) to ensure that expected batch
production is scheduled to coincide with sales demand.
• Responsible for accomplishment of stated batch production plan—task will
include monitoring of manpower required, scheduling overtime when needed,
ensuring adequate machine time available, eliminating any manufacturing-
related causes for rejected batches and departmental downtime.
• Schedule the production of Research & Development batches in the Production
Schedule—based on continual feedback, and input from R&D Department.
• Adherence to corporate governance policies.
• Responsible for organizing and overseeing Company’s Validation program to include facilities, equipment, process and cleaning validation.
SUPERVISORY RESPONSIBILITIES (DIRECT SUBORDINATES):
·Manufacturing Supervisors
·Packaging Supervisors
·Validation Supervisors
QUALIFICATIONS, EDUCATION and/or EXPERIENCE:
· Some college training (preferably a Bachelor’s Degree in a related field)
· 10 years experience in drug manufacturing related to applicable dosage forms
GOALS AND EVALUATION POINTS:
· Accomplishment of quarterly, and annual batch production goal
· Elimination of rejected batches due to processing errors
· Increase the percentage yield in manufactured batches
· Reduce the downtime, or indirect labor for manufacturing and packaging personnel through good planning and automation
· Reduce the number of finished goods inventory stock-outs
· Reduce the turnover of departmental personnel
· Reduce the lead time for scheduling of R&D batches
· Increase the utilization, or direct machine processing hours of the key manufacturing equipment
· Bring all equipment to operate at its highest stated rate by the manufacturer
· Adherence to President’s policy of providing weekly e-mail updates
Will Mechem
(646)784-0795
willm @ wjtsearch.com
Www.wjtsearch.com
www.linkedin.com/in/wmechem
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