Director, Manufacturing - Insulin

Company: Civica RX
Location: Petersburg
Posted on: November 17, 2023

Job Description:

The Director Manufacturing will direct the manufacturing operations for the Petersburg Insulin program at Civica and is a member of the site leadership team at Petersburg. Responsibilities of the position include building and leading the manufacturing organization for the Petersburg Insulin program including supporting the newly announced facility expansion that includes a dedicated 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 Civica 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
The essential functions include, but are not limited to the following:

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• Build and lead the manufacturing operations for Petersburg Insulin 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)
  
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  • 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.
    
  • Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates' skills and encourage growth.
    
  • 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.
    
  • Develop, implement, promote, and enforce site environmental, health, safety and security procedures for all personnel, equipment, materials, and activities at the site.
    
  • Thorough understanding and experience in developing and implementing state-of-the-art technical strategies through knowledge of industry practices, company history, culture, identity, and goals. -
    PIb48694b54312-31181-33260149

Keywords: Civica RX, Richmond , Director, Manufacturing - Insulin, Executive , Petersburg, Virginia