This position will provide direct leadership on the assigned shift in the manufacture of commercial product. Manage 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 in 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 SOPs, batch records, and/or protocols in support of equipment and manufacturing processes associated with the assigned manufacturing area.
Directly 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 the 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 a 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.
Competencies
Demonstrated experience leading/supervising exempt and non-exempt employees in a pharmaceutical manufacturing environment comparable to the proposed manufacturing area.
Demonstrates advanced skills, particularly in operational planning, product/process impact, personnel management, multitasking, delegation, and interpersonal relationship building.
Thorough knowledge of and experience in a manufacturing environment operating under cGMP.
Basic knowledge of chemistry, biology, and math; Demonstrated mechanical aptitude.
Excellent verbal and written communication skills; detailed oriented.
General knowledge of pharmaceutical finished product manufacture standards.
Ability to interview, hire and develop personnel.
Must be able to accomplish assignments on time.
Team Player committed to quality and working effectively with others.
Motivated self-starter.
Detail and results-oriented.
Dependable.
Well organized.
Efficient worker with good communication skills.
Physical Requirements:
Occasional periods of repetitive motion.
Ability to gown in an aseptic manner for clean room operations.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
Ability to operate all types of production equipment
Ability to read, understand, and follow company SOP guidelines.
Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs.
Ability to stand in steel-toed shoes for a minimum of 7 hrs.
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
