Senior Manufacturing Associate - Cell Therapy

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.

The Senior Manufacturing Associate will help to provide a safe, controlled work
environment in all areas of expertise. Be aware of the site safety objectives
and make sure they are communicated and understood. Senior Manufacturing Associate will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations.

The Senior Manufacturing Associate will assume the lead role during
manufacturing operations (i.e. harvest, vial filling, visual inspection, etc.).
Work with customer SMEs to transfer in and maintain customers' processes in
production facility. Attend technical and project meetings as necessary as the
manufacturing representative for processes during campaign preparation.
Provide/Arrange effective trainings for manufacturing staff related to any new
processes, batch records, or quality systems to be used in Cell Therapy .
Collaborate with CT Manufacturing project specialist team to incorporate
process and operational improvements into new customer processes in

Collaborate with CT Manufacturing team to determine equipment and materials
the suite will need to purchase in order to run the process. May act as fill in for
Manufacturing Supervisor.

Key responsibilities:

Support the definition and execution of Operational Readiness Activities for all Cell Therapy projects at LPO to include:

  • Collaboration with cross-functional teams and QA to support CT quality

  • systems and alignment with existing /prospective operations.

  • Support building & establishing the manufacturing team which may

  • include interviewing, onboarding and training of new colleagues.

  • Delivery of clinical & commercial material milestones and project

  • deliverables as required.

  • Support the development and execution of appropriate Safety,

  • Training, Gowning, Material, Visual Inspection, APS, Cleaning,

  • Scheduling, and EM strategies.

  • Support the definition and execution of all activity in compliance with

  • EHS requirements.

Support the definition and execution of Technical Transfer activities for CT
Projects at LPO to include.

  • Potentially assume Tech Transfer Lead role.

  • Operational input into material requirements, process execution &

  • procedure transfer.

  • Operational input into defining & executing manufacturing activity

  • related to Technical Transfer – water runs, training runs, particle runs,

  • engineering runs etc.

  • Enable timely delivery of milestones for the Technical Transfer.

  • Author, review, and approve documentation (electronic batch records,

  • SOPs, WIs, and logbooks) for completeness,

As project contributor collaborate with CT Manufacturing Leadership Team
to ensure.

  • Timely tracking of relevant project metrics

  • Progression of necessary purchase requisitions/orders and tracking

  • through delivery

  • Appropriate interaction with assigned external (customer) and internal

  • stakeholders.

Key requirements:

  • High School Diploma or Equivalent minimum; AS/BS preferred

  • Preferred area of study: Science related discipline

  • Significant experience in manufacturing; GMP setting preferred, and/or working knowledge as an Associate Level III in bio-pharm industry.

  • Proven logic and decision making abilities, critical thinking skills.

  • Strong written and verbal communication skills are required.

  • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.

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: R48694