Job Description

Key Responsibilities

• Lead and supervise daily execution of tasks to support the published production plan, ensuring completion through Team Leads and Manufacturing Associates.
• Provide hands-on leadership, coaching, and feedback to production teams across all shifts.
• Ensure robust and timely communication of operational and planning activities.
• Support the Line Manager in fulfilling RACI responsibilities (Responsibility, Accountability, Consultation, Information).
• Drive, write, and approve new SOPs, batch records, and protocols for equipment and manufacturing processes.
• Interface with support groups (Maintenance, Engineering, Quality Assurance/Control, Planning, Warehousing, Process Development) to maintain operational status and support production schedules.
• Support quality investigations, continuous improvement, and engineering/maintenance/quality activities.
• Initiate and author investigations for process deviations, ensuring timely product release and continuity of operations.
• Ensure compliance with cGMP and GDP in all manufacturing activities.
• Oversee facility and process maintenance within the area of responsibility.
• Collaborate with Development and Engineering for technology transfer of new products/processes.
• Ensure training and qualification of operators to support cGMP manufacturing.
• Supervise, develop, and evaluate Manufacturing Associates, including Senior OSD MFG Associates.

Competencies & Skills

• Demonstrated experience leading/supervising exempt and non-exempt employees in a pharmaceutical manufacturing environment, preferably OSD.
• Advanced skills in operational planning, personnel management, multitasking, delegation, and relationship building.
• Thorough knowledge of cGMP, GDP, and pharmaceutical manufacturing standards.
• Basic knowledge of chemistry, biology, and math; mechanical aptitude.
• Excellent verbal and written communication skills; detail-oriented.
• Ability to interview, hire, and develop personnel.
• Team player committed to quality and effective collaboration.
• Motivated self-starter; dependable, well-organized, and efficient.
• Ability to prioritize tasks and daily workflow; respond quickly to assignments.
• Intermediate computer/word processing/spreadsheet skills (e.g., Maximo, SAP, Oracle).
• Ability to troubleshoot compliance issues and escalate as needed.

Education & Experience

• High School Diploma or equivalent required; BS in Engineering, Scientific Discipline, or Business preferred.
• 5+ years' experience in pharmaceutical manufacturing or other regulated industry, preferably in OSD.
• 3-5 years of supervisory experience preferred.
• Experience with commercial and clinical pharmaceutical manufacturing and leadership roles.

Physical Requirements

• Ability to gown in an aseptic manner for clean room operations.
• Ability to operate multiple types of production equipment (e.g., Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils).
• Ability to lift/move up to 40 lbs; team lift up to 80 lbs.
• Ability to stand in steel-toed shoes for a up to 7 hours.
• Ability to stand or sit for extended periods (up to 2 hours at a time).
• Ability to push/pull equipment or product using a pallet jack.
• Must be medically cleared for respirator use (PAPR) and able to properly gown for potent controlled substance formulations.

Working Conditions

• Available for first shift, with possibility for overtime as necessary.
• Must be able to work in both office and manufacturing environments.

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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.