Senior Manufacturing Manager

United States, Portsmouth (New Hampshire)

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.

Serving as a member of the Manufacturing Leadership Team, the incumbent will be responsible for leading the establishment and technical transfer of all operations associated within areas of responsibility. Incumbent will be responsible for partnering with customers in delivering a safe and compliant operation both internally and externally. Driving continuous improvement activities, strategy development and delivery, as well as supporting organizational development and cultural leadership. Partner with Quality Assurance to develop, modify, implement and operate quality systems aligned with Lonza standards.

The Manufacturing Run Manager is responsible to manage the overall production readiness, execution, and batch delivery for the production of therapeutic proteins (API) under cGMP conditions in upstream and downstream production areas. Run Managers are expected to provide immediate response to Issues in Manufacturing Batch Production, on days, 7 days a week, and lead cross-functionally with management, support departments, customers to determine a clear understanding of the problem, immediate actions to mitigate risk to product quality, employee safety, or schedule, implement action to prevent recurrence and document the details of the event. The Run Manager is the technical point of contact for support group questions regarding production execution, and owner of the equipment in the suite, including change control assessments for equipment modifications or new equipment, owner/approver of Manufacturing relevant planned deviations and CAPAs ownership. They review/approve automation updates, validation and maintenance protocols and the primary point of contact for these changes. Run Managers are expected to manage suite readiness planners and expert trainers, and provide coaching/mentoring to manufacturing supervisors and associates.

*This position is set to report to work Monday - Friday 8:00 am- 5:00 pm*

Key responsibilities:

  • Driver of solving production issues in the USP or DSP manufacturing unit according to the common escalation guidelines; good collaboration with the support functions MSAT, Production Support, QA and the USP/ DSP production teams with expertise in solution finding and trouble shooting
  • Supervise and validate risk analysis and manufacturing work place inspections
  • Responsible for the approval of technical change request for the USP or DSP manufacturing unit
  • Responsible for setting up the training activities for mammalian cell culture as new technology in the operations unit
  • Representing the operational area in customer meetings, audits and regulatory inspections.
  • As a member of the Manufacturing Leadership Team responsible for all aspect of general production management such as housekeeping, staff behavior and control of general processes and installations
  • Execute innovation and improvement projects comprising general manufacturing aspects for the production plant
  • Own and manage Mfg. process specific change controls, planned deviations and CAPA’s. 
  • Drive and own improvement projects that support KPI’s, with a focus on cost, innovation, on-time delivery and quality
  • Generate and Manage Metrics

Key requirements:

  • Master or Bachelor degree in Chemistry, Chemical Engineering, Biotechnology, Bioengineering or related disciplines (with equivalent experience)
  • Significant experience in a leading position in Biopharma manufacturing, preferably Upstream and/or Downstream
  • Strong leadership skills and ability to communicate internally and externally at higher levels
  • Very good understanding of business and financial processes
  • Strong background in mammalian cell culture or downstream operations
  • Detail oriented with exceptional organizational skills and a structured and proactive working attitude
  • Open-minded for new ideas with a highly collaborative and strong team oriented attitude

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: R31262