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 
• 3-5 years of supervisory experience

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

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.