Vice President of Manufacturing

Company: Agcbio
Location: Seattle
Posted on: May 26, 2023

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit .
SUMMARY:
The Vice President, Manufacturing will oversee and direct the strategy and execution of AGC Biologics' 24/7 manufacturing operations at the Bothell site for pre-clinical, clinical, and commercial supply of therapeutic proteins that treat serious medical conditions. Functional areas within manufacturing include: Upstream Operations, Downstream Operations, Final Fill Bulk Drug Substance, Support, Strategic Operations, and Compliance. This role reports to the General Manager of AGC Biologics Bothell Site.
PRINCIPAL RESPONSIBILITIES:

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• Responsible for the development, implementation, oversight, and direction of all manufacturing processes, procedures, compliance measures, and standards.
  
• Oversee, manage, and develop Directors of Manufacturing, Process Excellence, Adjuvant and Microbial production, Compliance, Projects and Training.
  
• Serve as an integral member of the Seattle Site Leadership Team (LT), and collaborate with other LT members to inspire and mobilize the site to achieve vision and goals by contributing to site strategy decisions.
  
• Partner with the QA group to develop, implement and operate quality systems aligned with company standards as well as ensure alignment between Manufacturing and Quality in pursuit of interdependence and fulfilling quality goals.
  
• Ensuring the manufacturing facility is in a continuous state of readiness for production and cGMP audits. This will include completing quality work on schedule and in a safe manner, and ensuring the manufacturing area complies with all regulatory requirements.
  
• Develop a Master Plan maximizing the use of current site assets while developing plans with factoring in for future growth.Drive continuous improvement activities, strategy development and delivery, as well as supporting organizational development and cultural leadership.
  
• Assess the effectiveness and efficiency of site wide systems, processes and practices as well as oversee the planning and implementation of cost-effective initiatives that increase efficiency, effectiveness, throughput and regulatory compliance.
  
• Coordinate with other global sites on operational strategies/opportunities, capacity planning/optimization, technology/process development, and operational/quality initiatives. Ensure that all technology transfer, new project start-ups, and manufacturing campaigns are executed to company and customer requirements.
  
• Evaluate the results of the business and communicate with key stakeholders on current and anticipated performance to facilitate effective planning and decision-making. Lead the development of an operating plan that accounts for expanded capacity, improved productivity, asset flexibility, customer dynamics, and higher utilization rates to ensure that this business achieves overall financial goals for revenues, earnings, and ROI.
  
• Ensure good working relationships with all customers, suppliers and business partners including overall compliance with relevant FDA, OSHA, EPA and quality requirements.
  
  KNOWLEDGE, SKILLS & ABILITIES:
  
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  • Staff Leadership -Translate mission, vision, values into actionable goals and objectives. Provide adequate structure, direction and feedback. Create environment where staff feel valued, respected and empowered as well as show appreciation for and rewards individual and group excellence. Demonstrate high standards of ethics and fairness, and work through conflict and insures productive resolution.
    
  • Job Knowledge and Skills - Possess required knowledge and skills to successfully perform job. Rapidly embraces and applies new ideas and approaches where doing so adds value.
    
  • Results Orientation - Know how to get things done in an effective and efficient manner with available resources. Plan and prioritizes work, sets and accomplishes goals, and completes quality work on schedule. Maintain a sense of urgency in accomplishing work, and strive to improve company and individual performance. Take personal responsibility, leads by example and conscientious.
    
  • Decision Making -Make timely and sound decisions based on a combination of analysis, experience and judgment. Understand and take into consideration how decisions affects others.
    
  • Customer Focus/Team Work - Develop and maintain adequate customer satisfaction levels with internal and external audiences. Demonstrate a bias toward service, quality and teamwork. Build constructive and effective working relationships and is committed to the success of all stakeholders. Cultivate a culture of openness and information sharing. Demonstrate integrity and honesty in all communication - being able to take and provide constructive feedback.
    
    EDUCATION/EXPERIENCE:
    
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    • BS in Biology, Biochemistry, Molecular Biology or related technical discipline is required; MBA and/or a graduate degree in a related technical discipline is highly desired.
      
    • Significant leadership experience of a manufacturing organization with multi-product operations. Ideally, this experience will include the launch and commercialization of cGMP biopharmaceuticals.
      
    • Business and technically savvy executive who has successfully managed and optimized cGMP biologics manufacturing operations and/or relevant cGMP biotechnology businesses
      
    • Success in collaborating with prospective and current clients to build and maintain effective and trusting relationships.
      
    • Inherent in this role is the delivery of results through a combination of operational excellence, organizational development, and business management skills.
      
    • Proven capability to develop a strong market presence through customer service, high quality services, and technology leadership.
      
    • Demonstration of excellent communication skills to support team building, internal and external communications, and industry leadership opportunities.
      
    • Extensive skill and experience leading transformative manufacturing and productivity initiatives (e.g. lean/six sigma) to improve performance in a cGMP environment.
      
    • Experience in a rapidly growing, biopharmaceutical or related biotechnology business.
      
    • Equivalent education or experience may substitute for stated requirements.
      
      COMPENSATION RANGE:
      $229,000 - $314,000
      Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
      Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
      Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
      AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
      LI-LH1

Keywords: Agcbio, Seattle , Vice President of Manufacturing, Executive , Seattle, Washington