Director, Manufacturing

Job Description

The Director Manufacturing will direct the manufacturing operations for the company’s insulin program and is a member of the site leadership team. Responsibilities of the position include building and leading the manufacturing organization including supporting a high-speed cartridge filling line. This includes assisting in development of strategic vision and long-range planning for the site, as well as a focus on execution and team building to ensure compliance with company cultural tenets and sustainable and cost-effective manufacturing operations for the site. Champions a safe working environment and compliance with established policies, procedures, and guidelines for the engineering department and the overall site.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Build and lead the manufacturing operations for the program team and drive accountability for deliverables in a matrix environment.
• Provide the manufacturing leadership and management to ensure that the mission, core values and culture of the Company are put into practice at the site.
• Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, terminal sterilization, and packaging.
• Implement manufacturing shifts and support models for the Insulin program in alignment with site, company plans and member needs.
• Support the facility and equipment design, construction, process development/validation, and qualification.
• Establish performance and development plans for department staff, as standardized by the site and company, consistent with a culture of individual and team accountability and high performance.
• Establish manufacturing goals, milestones, objectives and key performance metrics.
• Mentors and coaches Manufacturing personnel in the use of Lean/Six Sigma methodologies and change management techniques to ensure timely completion of projects at the expected results.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in a pharmaceutical manufacturing environment.
• Must have 10+ years of biologics manufacturing experience with aseptic product manufacturing and/or injectable drugs.
• Demonstrated experience building a culture of continuous improvement by leveraging Operational
• Excellence methodologies and tools.
• Exceptional leadership abilities to inspire and motivate others to perform well, and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
• Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
• Ability to identify and resolve problems promptly and skillfully gather and analyze information using appropriate root cause analysis, FMEA, and other tools.
• Demonstrate effective project management skills, including use of appropriate tools and ongoing oversight.
• Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
• Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and maintain compliance with legal and regulatory requirements.