This position will provide direct leadership on the assigned shift in the manufacture of commercial product. Manages multi-disciplined teams in a pharmaceutical production area to ensure all manufacturing systems, production processes, equipment and final pharmaceutical product meets or exceeds Alkermes manufacturing standards, regulatory requirements and business objectives.

Responsibilities:

• Acts functionally as the operational leader on the floor during the shift with direct responsibility for Manufacturing Associates and operations executed by that shift
• Provides effective, ‘hands-on’ leadership to the production team as a whole, including Team Leaders and Manufacturing Associates, across all shifts, in the production of pharmaceutical drug product
• Plans and supervises daily execution of tasks to support published production plan and supervises completion of work through the Team Leads
• Supports the Line Manager complying with identified responsibilities (RACI- Responsibility, Accountability, Consultation and Information)
• Ensures robust and timely communication of defined operational / planning activities associated with the execution of daily production
• Provides Manufacturing Line Manager operational detail and planning as required to comply with production planning and to support Manager’s initiatives
• Drives / Writes / Approves new SOP’s, batch records, and/or protocols in support of equipment and manufacturing processes associated with the assigned manufacturing area
• The direct interface with support groups, including Facility and Process Maintenance, Engineering, Quality Assurance, Quality Control, Planning, Warehousing and Process Development, to ensure the operational status of the manufacturing area in support of published production schedule
• Supports quality investigations, continuous improvement efforts and engineering/maintenance/quality control/quality operations activities as they directly impact the functionality of the manufacturing area
• Initiate appropriate action when process deviations occur, authoring investigations when required, to ensure the timely release of product and/or continuity of operation of the manufacturing line
• Ensures compliance with cGMP in the manufacture of products
• Ensure maintenance and upkeep of the facility and process employed within the area of responsibility
• Directly interfaces with Development and Engineering in the Technology Transfer of new products or processes to the manufacturing area, with particular focus on the implementation, operation and procedural execution
• In conjunction with manufacturing training support, ensure opportunities for training for new and current operators
• Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical product
• Supervise, develop and evaluate Manufacturing Associates

Basic Requirements

• High School Diploma or equivalent.
• 5 years’ experience preferably in pharmaceutical manufacturing or other regulated industry.

Preferred Requirements

• Prefer BS in Engineering, Scientific Discipline or Business
• 3-5 years of supervisory experience

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