Technical Operations Specialist, Manufacturing

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 Operations Specialist is responsible to perform Manufacturing operational readiness activities which include, but not limited to, temporary Change Requests, SOPs, pre-campaign trainings and other associated tasks that are required prior to and during process campaigns. The Technical Operations Specialist is also involved in driving continuous improvement initiatives within Manufacturing.

The individual should have excellent communication skills and should be able to demonstrate agility with changing priorities on deliverables.

Key responsibilities:

• Initiate and complete temporary Change Requests along with corresponding redlining of batch records prior to the start of a required process run.
  
• Responsible for creation and revision of Manufacturing Standard Operating Procedures (SOPs) and other associated documents such as Performance Measures (PMs) etc.
  
• Create pre-campaign training package prior to upcoming campaign for operation related learnings from previous campaigns.
  
• Participate or Lead and facilitate continuous improvement initiatives pertaining to Manufacturing.
  
• Manage the execution of any other operational activities such as CAPAs, change request tasks, draft protocols for wet test execution, CSCC initiation etc. as assigned.
  
• Support with other activities such as defective material inspection and audit support.
  
• Collaborate interdepartmentally to drive assigned tasks to completions.
  
• Manage existing systems to track status of existing tasks such as SOP revisions, CAPAs/Change Requests to ensure timely closure.
  
• Identify areas of improvement and initiate tangible initiatives within Manufacturing leading to business aligned benefits.
  
• Provide guidance and mentorship to junior members of Tech Ops Team.
  
• Perform any other duties as assigned by your Lead/ Manager.
  

Key requirements:

• Degree in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines preferred.
  
• Knowledge of Engineering and Biopharmaceutical processing.
  
• Familiarity with FDA &
  EMA GMP and regulatory requirements.
  
• Strong communication skills – Clear and concise communication with internal and external stakeholders, effective communication of change management.
  
• Excellent written and oral presentation skills.
  
• Able to lead and effectively facilitate projects with cross-functional department involvement.
  
• Track record in completing projects under tight timelines.
  
• Strong proficiency in standard Microsoft Office applications e.G. MS Word, Excel and PowerPoint.
  

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.