Technical Writing Group Supervisor
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 has a phenomenal opportunity for Technical Writer Group Supervisor. The individual in this position will be responsible for support of manufacture and testing of Cell Therapy products by: Coordinating and supervising a team of technical writers to manage, draft, complete, and deliver Cell Therapy SOPs, MBRs and associated documents; Demonstrating sound judgment within generally defined practices and policies in ensuring schedules and performance requirements are met and develop and maintain site standards for Cell Therapy MBRs and associated documents.
- Supervise work necessary to write and revise manufacturing documents, including but not limited to Master Batch Records, Analytical SOPs, Quality Control Sheets, product labels, Material Specifications and Standard Operating Procedures
- Allocate resources to the completion of key site initiatives and projects based upon an assessment of project demand and required skill level. Devise Key MSAT Technical Writing team projects to support Cell Therapy and Viral Vector Manufacturing and Testing groups
- Directly supervise a team Cell Therapy and Viral Vector Technical Writers. Effectively manage the time and capacity of Cell Therapy and Viral Vector technical writing team, directing coverage to projects as necessary. Elevate as appropriate to management.
- Design and implement training systems to on-board additional Technical writing resources
- 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.
- Supervise continuous improvement of document format to make documents more usable to the target audience. Standardize and monitor compliance to standards
- Provide assistance and advice to external customers on the use of the Electronic Document Management System
- Work with Process Engineers on complex problems of diverse scope where analysis of situation or data requires evaluation of process and instructional factors.
- Bachelor’s degree with Extensive experience in this field or Master’s degree with Advanced experience in this field.
- 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.