Provides strategic scientific direction and support for the Holly Springs manufacturing departments to achieve supply targets and maximize capacity including the development and execution of strategy for optimising manufacturing productivity and output.
Support the Senior Director of Manufacturing on continuous improvement initiatives in the Bulk and Fill and Finish Departments, such as incorporate new technologies, establish best manufacturing practices and train manufacturing managers and associates in robust operation of production equipment.
Leads the development and embedding of a culture of risk-based continuous improvement and operational excellence within manufacturing.
Leads the transfer and implementation of product development projects from R&D into standard commercial manufacture and is responsible for strategic manufacturing input into R&D product development and process optimization projects.
Leads technology transfers to and from other manufacturing sites in line with the Seqirus global network manufacturing and supply strategy. Sub-duties include process fit risk assessments, oversight of the generation of production documentation, protocols and reports. Provide updates to program teams and management on progress and issues.
Provides strategic contributions to quality/GMP investigations and regulatory submissions. Leads strategic input as a manufacturing subject matter expert into key regulatory interactions and the authoring of CMC sections of regulatory submissions.
Leads company face to face interactions with auditors from external Regulatory Agencies within area of responsibility. Responsible for the identification and timely implementation of corrective actions to address audit findings in line with commitments to Regulator Agencies.
Leads a group of scientists and specialists conducting the daily collection, analysis and trending of production data and key performance indicators from Bulk and Fill and Finish departments. Proactively provides this information to key internal stakeholders with recommendations to address performance problems or to seize opportunities. Resolves process discrepancies and investigations.
Leads the development of five year strategic plans and annual OPEX and CAPEX budgets for the MS&T function, consistent with Seqirus global strategic and business plans. Establishes strategic objectives for the MS&T Department, monitors performance and optimizes the use of resources.
Keeps updated on technical advances in the design and operation of large scale production equipment. Provides recommendations to Senior Management of short and long term equipment upgrades in the production areas to ensure that the Holly Springs remains a state of the art production facility.
Hire, train, develop and lead MS&T staff to execute and achieve business strategy and objectives.
Develop, mentor and maintain an effective, productive and motivated team.
Establishes and fosters a high performance culture and environment of teamwork and proactive communication amongst staff and across departments.
Ensures compliance in accordance to Seqirus quality, compliance, safety, GMP, and regulatory standards at all times.
Ensures all members of the MS&T Department are proactively working to prevent health and/or safety incidents, minimizing environmental impacts, maintaining compliance and effectively responding to any EHS incidents that may occur within Seqirus / CSL’s EHS management system.
Bachelor’s degree in chemical/mechanical engineering, microbiology or cell engineering or equivalent is required. Master’s degree or PhD preferred.
Minimum 10 years’ related industry experiencerequired
At least 7 years of production management experiencepreferred
Demonstrated knowledge of GMPs and FDA requirements
Strong demonstrated team leadership skills
Strong project management skills preferred
Manufacturing Financial Knowledge – understanding of manufacturing financial accounting (budgeting, bills of materials, variances, recoveries, depreciation, working capital, etc.) and analytical skills to identify problems and opportunities.
Continue improvement orientation/ Ability to successfully lead change