Process Scientist II / III (MS&T)
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 part of the Manufacturing Sciences & Technology, Process Sciences team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk Operations. The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity.
This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that support Bulk Cell Culture, Fill-Finish, or Technology Transfer teams.
- Technical Expert for multiple assigned unit operations and processes in Upstream Bulk Manufacturing. Responsible for the reliability and robustness of assigned products and/or processes.
- Provides leadership, support and guidance to the Upstream Bulk Manufacturing Suite Team.
- Manages and maintains process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)
- Identifies and leads implementation of complex continuous improvement projects to improve yield, reliability, and process robustness.
- Leads the execution of process validations, annual monitoring batches, and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution.
- Leads complex product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
- Provides input to internal and regulatory audits as appropriate, serving as a lead SME during audits.
- Provides technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
- Ensures protocols are executed as intended and oversees execution of protocols.
- Uses scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
- Drives continuous improvement initiatives to proactively prevent process failures. Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
- Contributes to Annual Product Reviews and Product Quality Review for analysis and for contributing to process technology innovations.
- Process and equipment owners, providing fit-for-purpose risk assessments for technology transfers.
- Troubleshoots and investigates equipment and process issues within the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.
- Bachelor’s degree required. Degree in Engineering or Science discipline preferred.
- Minimum 3 years of related pharmaceutical/Biotech industry experience required. 5+ years of experience preferred.
- Strong experience and knowledge of statistical software preferred.
- Advanced knowledge of Excel.
- Experience with cell culture manufacturing preferred.
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, with direct experience supporting biannual or pre-approval inspections.
- Must have strong communication skills and good attention to detail.
- Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
- A solid understanding of engineering and/or scientific principles and the ability to apply your knowledge.
- Advanced troubleshooting skills with ability to mentor others.
- Excellent organizational, planning and time management skills.
- The ability to work effectively in both a team environment and an individual contributor role.
- Strong Process improvement experience, certification in Lean/Six Sigma preferred
- Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.