Assembly Line, Biotech and Pharmaceutical, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Service Management, Disease, Drug Manufacturing, Drug Products, Facilities and Maintenance, Leadership, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Manufacturing Operations Management, Manufacturing Requirements, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Products, Neurology, Neuroscience, Operational Communications, Operations Planning, Operations Processes, Pre-Clinical Development, Process Development, Process Manufacturing, Production Planning, Production Schedule, Production Support, Psychiatry and Mental Health, Quality Assurance, Quality Control, Regulatory Requirements, Standard Operating Procedures (SOP), Team Lead/Manager, Time Management, Warehousing
Essential Functions
- Acts functionally as the operational leader on the floor during a 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, focusing on 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 Team Leader(s) and Manufacturing Associates
- Works with Team Leads to ensure all their direct reports have clear goals and that the Team Leads are meeting regularly with their staff to review the goals and redirect work as needed.
Shift
Monday-Thursday, 3:00 pm to 1:30 am
Summary
This position will provide direct leadership across shifts in manufacturing clinical and commercial products. It will manage multi-disciplined teams of exempt and non-exempt members in a pharmaceutical production area to ensure that all manufacturing systems, production processes, equipment, and the final pharmaceutical product meet or exceed Alkermes' manufacturing standards, regulatory requirements, and business objectives.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.