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.
You will be responsible for the development and/ or revision of Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents e.g. Standard Operating Procedures (SOPs), Work Instructions (WIs) used in the execution of manufacturing processes and/ or operations. The individual should work very closely with Subject Matter Experts (SMEs) in Manufacturing Sciences and Technology (MSAT), Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), Validation (VAL) and any other relevant departments.
Develop new MBR (Master batch record)s, using existing MBR templates, in support of Technology Transfers
Maintain currency of MBRs for existing customers
Produce high-quality documentation that meets applicable standards/ requirements of the users
Write and edit technical information/ instructions in a manner to ensure content is factual and accurate
Meet with SMEs to ensure specialized topics are appropriately addressed/ discussed
Collaborate closely with relevant SMEs from various disciplines on documentation requirements
Manage the lifecycle of MBRs including, but not limited to creation, review, revision and approval of MBRs on product campaign basis
Maintain a system for tracking changes to be implemented in all upcoming product campaigns
Ensure MBRs adhere to approved template/ structure
Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs
Support change controls, deviations and introduction of New Stock Items (NSI)
Address comments arising from internal reviews and revise the documents accordingly.
Deliver MBRs with strict adherence to the production schedule
Provide assessments and insights to Change Requests from Technical Writing Team (TWT) perspective
Define Change Tasks associated with TWT
Ensure assigned CAPAs and Change Tasks are closed in a timely manner
Attend planning and briefing meetings
Perform any other duties as assigned by your Lead / Manager
BS in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/Microbiology) related disciplines preferred
Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage
Strong technical communication and writing skills
Excellent oral presentation skills
Effective interaction skills with MSAT, MFG, QA, customers and auditors
Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint
Advanced knowledge in Controlled Document Management System (DMS)
Track record in completing projects under tight timelines
Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts
Ability to influence peers and teams with no direct reporting lines
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.