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
