Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 is seeking an individual responsible for writing and revising analytical and manufacturing documents and act as a primary point of contact and advisor with regards to the creation of new production and analytical documents.
- Write and revise manufacturing documents, including but not limited to Master Batch Records, Analytical Standard Operating Procedures (SOPs), Quality Control Sheets, product labels, Material Specifications,
- Serve as primary advisor for documentation to Cell Therapy Clients
- Train and indirectly or directly supervise other technical writers
- Effectively manage the time of Cell Therapy CMO technical writing team, directing coverage to projects as necessary.
- Serve as a point of contact between client and Quality Control, Manufacturing and/or the commercial development organization when creating, updating and revising new and existing production and analytical documents
- Offer suggestions on improving document format to make documents more usable to the target audience.
- Conduct training on new and revised SOPs and as required due to manufacturing document format changes
- Provide assistance and advice to internal customers on the use of the Electronic Document Management System.
- Assist with tracking change orders in the department.
- Other document projects as assigned by the department manager.
- A majority of the work is done in an office environment with use of a personal computer or meetings held in conference rooms. Some of the work requires entry into a laboratory setting. While working in the laboratory environment appropriate gowning,
- Bachelor’s degree or Master’s degree
- Experience writing manufacturing/analytical documentation, Standard Operating Procedures, and Process Validation Protocols in a cGMP setting preferred.
- Cell culture, molecular biology or biotech/biopharma laboratory and/or manufacturing experience, preferably in a cGMP-manufacturing environment
- Technical writing including manufacturing documentation and Standard Operating Procedures
- GMP compliance knowledge; direct knowledge of relevant documentation requirements for cooperative manufacturing
- Part 11 compliance knowledge
- Computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
- Excellent Written and oral communication skills; listening skills; independent and self-directed
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.