Manager, Manufacturing (24x7)
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The incumbent will be a Manager, Manufacturing, overseeing the 24x7 shift Specialists Team supporting Bulk or Fill/Finish Flu Vaccine manufacturing. The role will ensure the timely production of quality drug substance or drug product in a safe, cost-efficient and environmentally responsible manner.Major Accountabilities:
- Provide direct management of the 24x7 shift engineering team, which provides direct technical support to the manufacturing supervisors and associates.
- Serve as manufacturing technical lead for process and mechanical issues, ensuring that the segment implements immediate corrective actions / counter measures.
- Responsible for overseeing training activities and performance while providing on the job coaching and feedback to associates.
- Accountable for batch production documents and procedures and ensures that all documents are reflective of the current process.
- Accountable for the timely completion of investigations that prevent reoccurrence.
- Successfully engages across the organization with peers and direct reports to set goals, budgets, objectives, and monitor performance to assure continuous improvement.
- Drives continuous improvement initiatives and implementation of Operational Excellence.
- Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
- Bachelors degree in Science or Engineering with 5 years prior relevant experience or no advanced degree and 7 Years of relevant industry experience.
- Minimum 5 years’ related industry experience required.
- Time in a technical role preferred.
- 3 years of management experience preferred.
- Production/manufacturing management is preferred.
- Knowledge of Regulatory Requirements and Experience interfacing with Regulatory agencies during external inspections and during regulatory response writing.
- Demonstrated knowledge of GMPs and FDA requirements