Supervisor, Manufacturing-OSD 1st Shift

Alkermes•Wilmington, OH

35d

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

3-5 years of supervisory experience preferred.
Experience with commercial and clinical pharmaceutical manufacturing and leadership roles.

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.