Director, Production

Company: Germer International
Location: Morristown
Posted on: May 24, 2023

Job Description:

Director of Production
A member of the Site Leadership Team, the Director of Production is responsible for the compounding, filling, and packaging of the drug onsite. This role will work cross-functionally with Quality, Engineering, Supply Chain, HR, Operational Excellence and Finance. The incumbent will be responsible for building strong working relationships across the site and driving employee engagement to next level and ultimately delivering safe and effective products to patients. The role is also responsible for building both a high performing team and high performing systems to drive and sustain business growth.
Responsibilities:

• 
  
• Direct drug production and packaging groups to ensure the timely delivery of manufacturing batches and successful implementation of new technology.
  
• Lead the Operational Readiness workstream for the transfer of the drug fill / finish to the company site.
  
• Assist the VP, US TechOps with establishing strategic direction for the drug manufacturing resources and activities and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and providing educational opportunities for team members.
  
• Maintain the operational facility in the highest level of cGMP compliance per FDA or other health authorities,
  
• Cross functional collaboration with Validation, Quality Assurance, groups to plan and implement the execution of cGMP activities in manufacturing operations for commercial operations.
  
• Ensure continued operational efficiencies are realized with reliable schedule adherence, and on time delivery of product, while maintaining the ability to react to changing customer requirements
  
• Share responsibility for short- and long-term resources and facility planning, and perform managerial duties as required, e.g. budgets, personnel performance appraisals, training, etc.
  
• Monitor and report progress of projects within agreed upon timelines, ensuring Company objectives are met.
  
• Responsible for participating and representing the drug manufacturing operations in audits as appropriate.
  
• Develop and lead a culture of learning, respect, and employee growth. Establish the department's strategic vision and mentor the manufacturing ops team towards goal achievement.
  
  Requirements:
  
  • 
    
  • Requires minimum Bachelor's degree in an Engineering or Scientific discipline
    
  • 10+ years' relevant experience with 5 years of production management experience
    
  • Experience working in Aseptic manufacturing; Good understanding of cGMP
    
  • Experienced in Manufacturing operations, tech transfer & validation, product formulation, process-technology and engineering competence
    
  • Experience in deviation and technical investigations and managing teams of > 20 is required
    
  • Outstanding interpersonal skills; ability to build strong relationships with cross-functional team members and lead through influence
    
  • Able to work under pressure and meet deadlines
    
  • Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
    
  • Strong follow-up skills and attention to detail.
    
  • Knowledge of Microsoft Word, Excel, Power Point, and Project.
    
  • Experience in a lean manufacturing environment
    

Keywords: Germer International, Newark , Director, Production, Professions , Morristown, New Jersey