Principle Scientist, Manufacturing Sciences & Technology (MS&T)

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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!

Job Description

Job Summary: The incumbent will be a leader within the global Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk and Fill-Finish Operations. The MS&T function provides strategic technical direction and support 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 and protein purification operations, formulation and fill-finish operations, and technology transfer inside Seqirus production network. This position also have the responsibility to work with regulatory group to support regulatory filing and address filing questions from regulatory authority. The Principle Scientist will be able to operate independently, interfacing as the SME for the cell based Influenza vaccine manufacturing platform across multiple disciplines (equipment or process based) both locally and globally. Major Accountabilities:
• Provide support to manufacturing as the primary point of contact for technical and operational process issues. Troubleshoot and investigate process problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide scientific information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
• Scientific Expert for the cell culture based influenza vaccine manufacturing processes, for the Flucelvax processes. Provides technical oversight and guidance to the MS&T team for protocol approvals, project scoping, and technology transfers. Assist with investigations related to product and process including complaints, out of expectation, out of specification, etc
• Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Identify and implement continuous improvement projects to improve yield, process robustness, and safety.
• Actively contribute to team meetings, interpret metrics and track project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged. Reviewer and approver of complex technical protocols, inclusive of Regulatory documentation (e.g. PAS, CBE-30, Annual Reports). Actively participate in after action review sessions and provide recommendations for improvement projects based on key performance indicators and observed trends.
• Main interface between the Technical Development Function and the rest of the MS&T teams as well as Manufacturing Operations. Actively participated in scientific meetings to track development activities, provides feedback to the Technical Development teams about the manufacturability of process as it is being developed. Communicates back to MS&T and Manufacturing about the progress of development activities.
• Lead technical discussions during internal and regulatory audits, with responsibilities to lead technical responses/commitments as required.
• Ability to broadly assess and lead process risk assessments (for example within the frame of technology transfers) of high complexity and scope.

• Bachelor's degree required. PhD Degree in an engineering or science discipline preferred.
• Minimum 5+ years' relevant experience required; prefer candidates with 10+ years overall experience and 8+ years' experience in pharmaceutical/biotech operations in a technical role.
• Industry expert in processes utilized in a biopharmaceutical or vaccine manufacturing process.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, inclusive of direct support during audits
• Experience on filing regulatory document and addressing regulatory issues and questions
• Strong cross-functional leadership, organizational planning and project management skills, in addition to technical knowledge
• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.