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Job Title: Senior Manufacturing Manager
Manage Bio-pharmaceutical manufacturing activities that include production processes and budgeting, and is accountable for departmental manufacturing performance to plan. Total department staff may consist of up to 3 direct report production supervisors and 20 indirect reports.
This person is responsible for the recruitment, development, and mentoring of supervisory personnel involved with the manufacturing process. Cross-shift and cross-functional communications is an integral part of this position. Additionally, this person will be responsible for the management and coordination of projects outside of the daily manufacturing operations. This position requires excellent interpersonal skills, both verbal and written, and the ability to effectively communicate issues and resolutions to Manufacturing personnel and other department management. Thorough understanding of the manufacturing processes and ability to accurately review GMP documentation and other investigations is required. This person will also be expected to represent their MFG area on inter-departmental and cross-site initiatives.
Cross-shift and cross-functional communication
Timely and accurate resolutions of deviations
Coordination of validation exercises
Cross functional meeting representative
Develops and implements production resources, equipment and staff sufficient to support production plan requirements which may run across multiple shifts.
Directly responsible for hiring, training and managing production activities.
Accountable for the completion of project or product manufacturing goals. Supports transfer of new products into manufacturing in a timely manner. Assures quality manufacture of product within all applicable regulatory guidelines.
Ensures that employees are trained in all required procedures, documentation and current safety practices.
Develops departmental goals and objectives in line with Divisional goals. Ensures career development plans are in place for employees.
Proven ability to serve in a leadership role, with ability to supervise personnel, communicate effectively in written and verbal manner.
Other responsibilities as required.
A BS in a science related discipline and 3-5 years relevant experience is preferred
Ability to manage manufacturing operations while effectively utilizing materials, labor and equipment.
Must have Excellent GMP documentation skills. A Full understanding of bio-processing (Purification, Cell Culture, Dispensing operations, and Production support)
A Fundamental knowledge of validation is required. Must have good troubleshooting skills.
Interpersonal Skills and Interactions:
Must have strong leadership and negotiating skills. Person should be able to work in a team environment.
Able to interact with many different functional areas.
Excellent verbal and written communication skills required.
Strong presentation skills.
Good listener, ability to interact with all levels of personnel.
Must be able to add value to the company and achieve its growth objectives through high quality, cost efficient manufacturing support.
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