Technical Writer, Cell & Gene Therapy

at  Lonza

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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The Technical Writer is 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 here onsite at Lonza Singapore. You will 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. The individual should have good understanding of manufacturing processes and operational knowledge of manufacturing equipment. In addition, attention to details is complimentary attribute required to ensure accuracies of the MBRs.

KEY REQUIREMENTS:

• Bachelor Degree 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.
• 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.
• Competencies required: Business Acumen, Customer Focus, Driving Results, Leadership, Collaboration, Agility.
  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

• Develop new MBRs and Work instruction (WI), using existing templates, in support of Technology Transfers and revise existing ones ensuring adherence to approved template/ structure.
• 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.
• Collaborate closely with relevant SMEs/ customers on documentation requirements to ensure specialized topics and comments from internal review are appropriately addressed/ discussed.
• Generate Aseptic Process Simulation Summary Report.
• Manage the lifecycle of MBRs including, but not limited to creation, review, revision and approval on product campaign basis.
• Maintain a system for tracking changes to be implemented in all upcoming product campaigns.
• Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs.
• Deliver MBRs/ WIs with strict adherence to the production schedule.
• Support change request process; provide assessments and insights to Change Requests as needed & define Change Tasks as needed and close tasks in a timely manner.
• Close assigned CAPAs in a timely manner.
• Attend planning and briefing meetings
• Participate in continuous improvement projects.
• Perform any other duties as assigned by your Lead / Manager.