General Manager & Site Head (SEA)

AGC BiologicsBothell, WA
Onsite

About The Position

The Site Head & General Manager will have profit and loss responsibility for AGC Biologics' Seattle, Washington facility. The Site Head & General Manager will be responsible for continuing the development of a biopharmaceutical contract manufacturing organization that will be recognized for a culture of excellent service, on-time deliveries, and the production of high-quality cGMP biologic materials. Critical to this role will be building a collaborative, professional, and talented organization into a business-minded, efficient, and reliable operation producing clinical and commercial scale cGMP biologic materials. This role will work closely with colleagues in Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan to ensure the Seattle business leverages and integrates AGC Biologics' combined global capabilities. This critical leadership position requires a combination of strategic and tactical thinking, extensive operational experience (multi-product clinical and commercial manufacturing), strong business acumen, keen systems and process orientation, and excellent people skills.

Requirements

  • Bachelor's degree in Biology, Biochemistry, Molecular Biology, or a related technical discipline is required.
  • Qualified candidates will be business- and technically savvy executives who have successfully managed and optimized cGMP biologics manufacturing operations and/or relevant cGMP biotechnology businesses.
  • Significant leadership experience in one or more operations functions (e.g., Manufacturing, Quality, Process Development, or MSAT).
  • Prior experience with mammalian and microbial manufacturing is required.
  • Experience partnering with prospective and existing clients before and throughout project engagements.
  • Demonstrated leadership of a large-scale, multi-product manufacturing organization.
  • Excellent communication skills to support team building, internal and external communications, and industry leadership.

Nice To Haves

  • An MBA and/or a graduate degree in a related technical discipline is highly preferred.
  • Experience launching and commercializing cGMP biopharmaceuticals is highly desirable.
  • Proven ability to deliver results through operational excellence, organizational development, and business management.
  • Demonstrated ability to build a strong market presence through customer service, high-quality services, and technology leadership.
  • Experience applying Lean, Six Sigma, or similar manufacturing and productivity methodologies to improve performance in a cGMP environment is highly preferred.

Responsibilities

  • Lead the development and maintenance of a high-performing organization encompassing operational excellence (efficiency, productivity, and quality), cGMP regulatory compliance, and customer service.
  • Lead the Seattle Leadership Team through the standards of situational leadership practices matching AGC Biologics Leadership Behaviors with performance needs.
  • Provide strong, collaborative, and decisive leadership through direct, open, and honest communication at all levels of the organization.
  • Develop a highly motivated, empowered workforce through a combination of individual development, external hiring, and recognition and reward systems that result in a highly qualified, engaged, and motivated team across all levels of the business.
  • Provide regular communications to inspire the organization in its continued transformation into a successful contract manufacturing organization.
  • Drive continuous improvements of site-wide systems, processes, and practices.
  • Oversee the planning and implementation of effective initiatives that increase safety, regulatory compliance, customer satisfaction, efficiency, effectiveness, and throughput.
  • Coordinate with AGC Biologics sites across the network on operational strategies and opportunities, capacity planning and optimization, technology and process development, and operational and quality initiatives.
  • Ensure that all technology transfer, new project start-ups, and manufacturing campaigns are executed to company and customer requirements.
  • Ensure the development of a world-class regulatory and quality environment through a strong commitment to cGMP requirements for clinical and commercial scale production.
  • Lead the development and implementation of a strategic site master plan to further grow business at the site and ensure sustainable success.
  • Foster an environment for world-class manufacturing through team member involvement, continuous improvement, regulatory and environmental leadership, and organizational development.
  • Evaluate the results of the business and communicate with key stakeholders on current and anticipated performance to facilitate effective planning and decision-making.
  • Develop a customer service-oriented culture, including the ability to leverage global technical capabilities for closing new business and building strong relationships with customers and other external organizations.
  • Ensure good working relationships with all customers, suppliers, and business partners, including overall compliance with relevant regulatory requirements (e.g., EHS, GMP).

Benefits

  • Profit and loss responsibility
  • Development of a biopharmaceutical contract manufacturing organization
  • Culture of excellent service, on-time deliveries, and high-quality cGMP biologic materials
  • Collaborative, professional, and talented organization
  • Business-minded, efficient, and reliable operation
  • Clinical and commercial scale cGMP biologic materials production
  • Strategic and tactical thinking
  • Extensive operational experience (multi-product clinical and commercial manufacturing)
  • Strong business acumen
  • Keen systems and process orientation
  • Excellent people skills
  • Leadership, direction, and operational management
  • World-class contract manufacturing organization
  • Short- and long-term financial goals
  • High-performing organization
  • Operational excellence (efficiency, productivity, and quality)
  • cGMP regulatory compliance
  • Customer service
  • Situational leadership practices
  • AGC Biologics Leadership Behaviors
  • Strong, collaborative, and decisive leadership
  • Direct, open, and honest communication
  • Highly motivated, empowered workforce
  • Individual development
  • External hiring
  • Recognition and reward systems
  • Highly qualified, engaged, and motivated team
  • Regular communications
  • Continuous improvements of site-wide systems, processes, and practices
  • Effective initiatives that increase safety, regulatory compliance, customer satisfaction, efficiency, effectiveness, and throughput
  • Coordination with AGC Biologics sites across the network
  • Operational strategies and opportunities
  • Capacity planning and optimization
  • Technology and process development
  • Operational and quality initiatives
  • Technology transfer, new project start-ups, and manufacturing campaigns
  • World-class regulatory and quality environment
  • Strategic site master plan
  • Sustainable success
  • World-class manufacturing
  • Team member involvement
  • Organizational development
  • Evaluation of business results
  • Communication with key stakeholders
  • Effective planning and decision-making
  • Customer service-oriented culture
  • Leveraging global technical capabilities
  • Closing new business
  • Strong relationships with customers and other external organizations
  • Good working relationships with all customers, suppliers, and business partners
  • Compliance with relevant regulatory requirements (e.g., EHS, GMP)
  • Translates AGC Biologics' mission, vision, purpose, and values into actionable goals and objectives
  • Adequate structure, direction, and feedback
  • Environment where team members feel valued, respected, and empowered
  • Appreciation for and rewards individual and group excellence
  • High standards of ethics and fairness
  • Appropriate risk-taking
  • Encourages team members to take risks
  • Works through conflict and ensures productive resolution
  • Maintains confidentiality of private and sensitive information
  • Required knowledge and skills to successfully perform the job
  • Rapidly embraces and applies new ideas and approaches
  • Gets things done effectively and efficiently with available resources
  • Plans and prioritizes work
  • Sets and accomplishes goals
  • Completes quality work on schedule
  • Maintains a sense of urgency
  • Strives to improve company and individual performance
  • Takes personal responsibility
  • Leads by example
  • Demonstrates conscientiousness
  • Shows initiative and commitment to achieving company success
  • Timely and sound decisions based on analysis, experience, and good judgment
  • Consults others as appropriate
  • Understands and considers how decisions impact others
  • Develops and maintains strong customer satisfaction with internal and external stakeholders
  • Bias toward service, quality, and teamwork
  • Builds constructive and effective working relationships
  • Committed to the success of all stakeholders
  • Cultivates a culture of openness and information sharing
  • Demonstrates integrity and honesty in all communications
  • Willing to speak the truth and advocate positions even when unpopular
  • Provides constructive feedback and avoids blaming others
  • COMPENSATION RANGE: $270,160.00 - $371,470, depending on experience
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