Vice President/Senior Vice President Manufacturing

Requirements

The ideal candidate will have a strong background in biologics manufacturing and a proven track record of successfully managing complex manufacturing processes while ensuring quality and regulatory standards adherence. This role requires a strategic thinker who can effectively optimize manufacturing operations, foster innovation, and lead cross-functional teams to deliver high-quality products on time and within budget.

Location: On-site - New Jersey

Responsibilities:

• Develop and execute the overall manufacturing strategy in alignment with the company's goals and objectives, with a particular focus on biologics production and supply chain management
• Provide strong leadership and guidance to the manufacturing team, fostering a culture of continuous improvement, collaboration, and accountability
• Oversee all aspects of biologics manufacturing operations, including process development, technology transfer, scale-up, and commercial production, while ensuring compliance with cGMP regulations and industry standards
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to ensure seamless integration of manufacturing activities across the organization
• Lead efforts to optimize manufacturing processes, improve efficiencies, and reduce costs while maintaining high-quality standards and meeting production targets
• Drive the implementation and adoption of advanced manufacturing technologies and automation systems to enhance productivity, reduce cycle times, and increase manufacturing capacity
• Establish and maintain effective relationships with key suppliers and contract manufacturing organizations (CMOs) to ensure reliable and cost-effective supply of raw materials, intermediates, and finished products
• Collaborate with the Quality Assurance team to establish and maintain a robust quality management system, ensuring compliance with applicable regulations and industry best practices
• Develop and monitor key performance indicators (KPIs) to track manufacturing performance, identify areas for improvement, and drive operational excellence initiatives
• Stay abreast of industry trends, technological advancements, and regulatory changes related to biologics manufacturing and supply chain management, and proactively recommend strategies to maintain a competitive edge
  
  
  

Experience/Qualifications:

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred
• Minimum of 10 years of progressive leadership experience in biologics manufacturing, with a strong focus on biopharmaceuticals
• Extensive knowledge of cGMP regulations and quality systems applicable to biologics manufacturing
• Proven track record of successfully managing and optimizing biologics manufacturing processes, including process development, scale-up, and commercial production
• Demonstrated experience in implementing advanced manufacturing technologies and automation systems in a biologics manufacturing environment
• Strong leadership and team-building skills, with the ability to effectively motivate and develop high-performing teams
• Excellent problem-solving and decision-making abilities, with a strategic mindset and the ability to think critically in complex situations
• Outstanding communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, senior management, and external partners
• Demonstrated ability to manage multiple priorities and projects simultaneously, while ensuring timely completion and adherence to budgetary constraints
• Knowledge of biologics supply chain management and experience in establishing and maintaining relationships with suppliers