- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
- Reporting to the relevant Manufacturing Manager, the primary role of the Biotechnician is to perform day to day activities within Cell Culture, Purification and Process Services within the Manufacturing Group.
- They will be responsible for ensuring the manufacturing team has a successful site start up, process validation and product launch activities.
- Main areas of responsibility:
- Performing, monitoring and troubleshooting of the cell culture, purification or support operations within Manufacturing.
- Monitoring and reporting of process performance using statistical process control.
- Support of Commissioning and Qualification activities.
- Preparation, updating and execution of Batch Records, SOPs and other GMP documentation.
- Provide process and equipment related training as required within the Manufacturing Department.
- Troubleshooting of process specific equipment.
- Troubleshooting of DCS (e.g. Delta V) and PLC control systems.
- Authoring, investigating and resolving quality deviations raised within the Manufacturing Department.
- Participate in/ Lead Cross Functional team initiatives when required.
- Participate in the execution of validation protocols.
- Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Completion of assigned tasks to support manufacture of quality biopharmaceuticals in accordance with cGMP and EHS requirements.
- Use Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
- Working flexible shift patterns to meet business needs and Manufacturing schedule
EDUCATION AND EXPERIENCE
- Bachelor degree in Biotechnology, Chemical or Biochemical Engineering, Biochemistry or Bio-systems
- Engineering or related field or equivalent experience is preferred.
- Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Work closely with Process Development, Manufacturing Science Group, Quality Operations, Facility Services and Manufacturing personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
- This description is not intended to be all-inclusive or a limitation of the duties of the position.
- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.