Director of Operations / Manufacturing - Pharmaceuticals (Michigan)

The Company

Our client is a global pharmaceutical company that develops, manufactures, markets, and sells various pharmaceutical products worldwide.

Purpose of the Position

Reporting to the Site General Manager, the Director will oversee the establishment, implementation, maintenance, and sterilization of production equipment and facilities at the companys Midwest US - based aseptic facility. These responsibilities include but are not limited to raw material sampling, dispensing, product formulation, and aseptic / sterile primary packaging of products in plastic bottles, vials or syringes with oversight for inspection, secondary labelling, and packaging of the finished product.

He / she will oversee the execution of commercial production and support developmental and technical transfer production activities across three shifts. Our client is looking for a hands-on, operational change agent that can foster innovation and better continuous improvement practices.

The ideal candidate will bring proven team leadership and experience in managing manufacturing site filling operations with diverse pharmaceutical and sterile injectable products at similar scope / scale. This individual will live within commuting distance to the site (Midwestern US) and / or be open to relocation (assistance provided), with the ability to be onsite ~4-5 days per week.

Key Responsibilities

Operations and Compliance :

• Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
• Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
• Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives
• Sets priorities to meet internal cycle times and delivery schedules. Maintains proper staffing and training levels to meet requirements.
• Develops and maintains a safe manufacturing environment in accordance with plant and corporate policies in addition to local, state, and federal EHS regulations. Participates in safety meetings, investigates accidents, ensures proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
• Performs site performance assessments and risk assessments based on business development and new product / process / technical transfer activities associated with employee operations, GMP Compliance, and safety.
• Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
• Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments. Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.

Budgetary Management & Delivery Performance :

Team Supervisory & Development :

Team & Cultural Leadership :

The Candidate

Experience and Professional Qualifications

Skills and Competencies

Physical Requirements for the role include being able to :