Head of Manufacturing

United States, Hayward (California)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As part of the Site Leadership Team, the Head of Manufacturing is responsible for the implementation, development and flawless execution of the site’s cGMP Upstream Processing (USP)and Downstream Processing (DSP) manufacturing strategies. This includes management of Manufacturing Support and cGMP Quality Document teams. The role is suited for a seasoned manufacturing professional with experience in the clinical and commercial production of therapeutic proteins and protein raw materials in a CMO environment.  This role will leverage the candidate’s knowledge and skills in the strategic development and day to day operation of a dynamic 24/7 cGMP production facility.

The Head of Manufacturing must facilitate, develop and maintain strong working relationships with internal stakeholders, ensuring that all parties are aligned with operational requirements, while maintaining EHS, quality, and efficiency goals and objectives. The role is accountable for the management, coaching, development and performance monitoring of the Manufacturing team.

Key responsibilities:

  • Promote  and  embed  a  world-class EHS culture  within  the team,  ensuring compliance  to  applicable  regulations,  legislation  and  company  policies  at  all times.
  • Ensure  departmental  adherence  to  policies,  procedures,  ethics  and  industry regulations.   
  • Ensure cGMP,  EHS and  Data  Integrity compliance  at  all  times. 
  • Manage and maintain Quality Management System records in accordance with stipulated  timelines.   
  • Represent Manufacturing in  internal,  customer  and  regulatory audits and provide audit support where required.
  • Maintain a high level of customer  satisfaction  through  attendance  and  active participation  in  stakeholder  meetings,   ensuring  timely   delivery   of  agreed departmental actions and objectives.
  • Manage,  coach  and  develop all members of the Manufacturing team by conducting and actively managing Performance  Reviews, Individual Development Plans, Succession Planning, 1:1s, and training. 
  • Oversee recruitment updates/changes and handle all disciplinary matters in a timely manner and consistent with company policy.
  • Manage and deploy team resources to maintain coverage of trained team members across all shifts, achievement of agreed upon production schedules, control bottleneck process performance and resolve operational constraints to improve productivity.
  • Review and align manufacturing schedule with the production plan and supply and ensure that rationale behind adjustments changes are communicated to stakeholders.
  • Attend appropriate Hoshin level 0/1/2/3 meetings to ensure performance adherence to the KPIs. Analyze and interpret data, identify and implement solutions accordingly to improve performance, efficiency or correct negative trends. 
  • Provide regular performance updates to Site Leadership through daily site Gemba updates.
  • Seek new and innovative ways to improve the efficiency and cost effectiveness of Manufacturing departments. Use Lean, 6S, and Six Sigma methodologies to improve departmental performance and leverage available resources  (e.g.  OE  team,  Stakeholders, SMEs, Lonza Network).   
  • Implement and foster a culture of Quality and Compliance focus and continuous improvement.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R34289