Director, Aseptic Operations - Sterile Fill

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Director of Operations at the Rochester MI facility leads the establishment, implementation, maintenance and execution of: cleaning, sanitization, and/or sterilization of production equipment and facilities; raw material sampling, dispensing and product formulation; aseptic/sterile primary packaging of liquid, suspension, or lyophilized product in plastic bottles, vials or syringes; inspection, secondary labeling and packaging of the finished product. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives and sustain site’s positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance. The individual must have the ability to coordinate work between functions to ensure alignment with overall site Vision, Mission and Execution Strategy.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

• Span of Control: oversight of five (5) budgetary departments representing seven (7) operational working units: 1) Sanitation, Drug & Chemical Dispensing, Bulk Manufacturing; 2) Preparation Services; 3) Sterile Filling; 4) Inspection & Packaging, and 5) Manufacturing Administration
• Operating Budget  ~$15M; Spend/signing authority at $25K

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Operations

• Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
• 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.
• Maintains proper staffing and training levels to meet requirements. 
• Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.
• Sets priorities to meet internal cycle times and delivery schedules.
• Assure adequate maintenance of department machinery and supplies. 
• Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.
• Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations

20%

Compliance

• Develops and maintains a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations.  Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
• Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement)
• Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Performs assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.
• Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.
• Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.
• Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.

20%

Supervisory Responsibilities

• Interviews, hires, and ensures training of employees; plans, assigns, and directs work; appraises performance; rewards and redirects employee’s activities; addresses complaints and reso