Director of Manufacturing

Job Description

Director of Manufacturing

This role balances the urgency of daily first shift operations with the pursuit of long-term goals while ensuring the highest standards of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives. The individual must have the ability to coordinate work between functions to ensure alignment with overall department vision and promote urgency, ownership, and accountability across the organization.

• Manages the execution of first shift manufacturing to meet quality, client, and financial objectives as well as supporting technical transfer of clinical production activities across shifts.
• Responsible for overseeing the finite scheduling of aseptic formulation and filling operations to ensure timely batch preparation and filling in alignment with production plans, quality standards, and manufacturing priorities.
• Partner with Quality and Operational Excellence manufacturing management team to ensure consistent product quality; drive efforts to create a right-first time (RFT) culture, reduce and eliminate human errors, manage deviations to ensure true root cause is identified and on time closure is achieved and continuously improve operational performance.
• Proactively identify, assess, and mitigate operational, quality, and organizational risks. Escalate key risks and issues.
• Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.) Maintain high standards of quality, compliance, and safety through leadership by example.
• Implement and drive continuous improvement initiatives across manufacturing operations, leveraging data-driven insights and Operation Excellence methodologies
• Develop, implement, and maintain KPIs aligned with site objectives to measure and monitor manufacturing performance across key areas including productivity, yield, utilization, cycle times, compliance, and cost efficiency. Regularly review and refine KPI metrics to reflect changes in business needs and operational priorities. Provides management reporting through use of department metrics aligned with site objectives and balanced scorecard.
• Balances team and individual responsibilities and exhibits objectivity and openness to others' views. Facilitate effective communication between clients and internal stakeholders to ensure alignment of site objectives
• Works to maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations.
• Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Ensure compliance with all local, state, federal, FDA, OSHA, cGMP or other applicable regulations
• Balance team and individual responsibilities
• Exhibit objectivity and openness to others' views
• Give and welcome feedback
• Contributes to building a positive team spirit
• Put success of team above own interests
• Able to build morale and group commitments to goals and objectives
• Support everyone's efforts to succeed

Experience:

• 8 to 10 years of supervisory/leadership experience in a GMP manufacturing environment with specific involvement with Operations, Quality and Compliance Management
• Direct parenteral manufacturing/quality experience preferred
• Experience in a Lean, Six Sigma or similar Operational Excellence system
• Bachelor’s degree from an accredited college or university with a major in Science, Engineering is preferred
• Excellent teamwork
• Ability to communicate clearly and cooperate with other staff members to achieve overall organizational objectives
• Ability to coordinate work between functions to ensure alignment with overall department vision
• Ability to promote urgency, ownership, and accountability across the organization
• Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations
• Knowledge of FDA regulations, GMP/GLP/GCP, CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes), Lean Manufacturing, Six-Sigma
• Ability to set and achieve challenging goals
• Ability to demonstrate persistence and overcome obstacles