Manufacturing Project Specialist Manager

United States, Houston (Texas)

Viral Vector Manufacturing Project Specialist Manager

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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is still growing. We are looking for professionals to grow with us and we have this exciting opportunity in Viral Vector Therapy.  The Manufacturing Project Specialist Manager is responsible to lead manufacturing projects in partnership with the Manufacturing Asset Team and drive cross-functionality projects to completion. This person will work closely with Manufacturing Management to drive the achievement of department goals, interdepartmental readiness and batch release requirements, and maintain due dates to support the on time release of batches.

Key Responsibilities:

  • Key contributor to technology transfer and all activities directly supporting campaign readiness.
  • Responsible for the planning, preparation, implementation and delivery of projects assigned.
  • Work cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update procedures or steps, identify and escalate risks, communicate changes and plan for execution.
  • Owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance.
  •  Ensure manufacturing CAPA closures, Change Controls and Deviations are progressing to the agreed upon timelines. In addition to managing the timelines of the Manufacturing Quality Documents.  Will be assigned large scale CAPA’s to own.
  • Perform Validation Protocol and Batch Record review and various tasks to support Lot Release Requirements and continued production.
  • Effectively represent his or her  functional area and on site initiatives. Capable interfacing with Lonza customers.
  • Generate and manage department metrics.
  • Perform other duties as assigned.

Key Requirements:

  • B.S. Biotechnology, Biology, Chemistry or equivalent.
  • Significant experience leading production/ manufacturing projects from concept-to- completion in a pharmaceutical/ biotechnology production environment.
  • Significant leadership experience.  Must be able to grow and develop a team of direct reports.
  • Strong working knowledge of cGMP/ FDA regulations.
  • Exceptional upstream, downstream, aseptic manufacturing process background.
  • Strong process improvement/ Lean background.
  • Well verse with client facing responsibilities.
  • Fluent in quality systems.
  • Proficient with MS Office (Word, Project PowerPoint and Excel).
  • Excellent communication skills both verbal and written.

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: R37272