Position Summary

The Director of Manufacturing balances the urgency of daily 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.

Duties And Responsibilities

Manage the execution of shift manufacturing to meet quality, client, and financial objectives as well as supporting technical transfer of clinical production activities across shifts
Oversee 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, escalating key risks and issues
Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) while maintaining 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
Provide management reporting through use of department metrics aligned with site objectives and balanced scorecard
Balance team and individual responsibilities and exhibit objectivity and openness to others' views
Facilitate effective communication between clients and internal stakeholders to ensure alignment of site objectives
Work to maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations
Other duties as assigned

Regulatory Responsibilities

Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.)
Ensure compliance with all local, state, federal, FDA, OSHA, cGMP or other applicable regulations

Supervisory Responsibilities

Balance team and individual responsibilities
Exhibit objectivity and openness to others' views
Give and welcome feedback
Contribute to building a positive team spirit
Put success of team above own interests
Build morale and group commitments to goals and objectives
Support everyone's efforts to succeed

Experience

Eight (8) to ten (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

Education

Bachelor’s degree from an accredited college or university with a major in Science, Engineering or is preferred
An equivalent combination of education and experience may be considered

Knowledge, Skills & Abilities

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
Ability to measure self against standards of excellence
Ability to take calculated risks to accomplish goals

Physical Requirements

Ability to meet gowning requirements for cleanroom activities
Able to lift up to approximately 15-50 pounds frequently and up to 50 lbs. occasionally
Frequent standing and walking throughout the facility
Use of both hands and arms in repetitive motion
Fine and gross motor skills
Satisfactory audio-visual acuity

Sharp Sterile Manufacturing

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