The Process Scientist/Engineer will provide technical expertise in Upstream/Downstream processing to support the commercial manufacturing of theurapeutic proteins in a mammalian cell culture facility. The role will ensure leadership for on-going optimization of the Upstream/Downstream process and act as a manufacturing Subject Matter Expert (SME) in supporting and ensuring the continued manufacture and supply of quality biologic products.
Reporting into the Manufacturing Technology (MT) Lead, the Upstream/Downstream Process Scientist/Engineer will be responsible for ensuring that manufacturing processes are validated and maintained within their validated states.
A key skill for the successful candidate will be the ability to deliver tech transfer activities for new products. Provide previous technical experience and process knowledge to support on-going optimisation of the upstream/downstream process. The ideal candidate will be a key contact in technical trouble-shooting of upstream/downstream unit operations and leading/supporting major process investigations at the request of the business.
The scope of this role will also ensure the delivery of process excellence and reliability across all areas of the manufacturing process. Process Scientist/Engineer will also provide input to ensure the facility design meets end user requirements.
The successful candidate may be required to support both upstream and downstream areas as needed and in line with areas of expertise.
Essential Duties and Responsibilities
· Essential duties and responsibilities for upstream and or downstream include, but are not limited to:
· Provide expertise for all aspects of mammalian cell culture process; vial thaw through to harvest.
· Provide SME support for cell harvest technologies e.g., centrifugation, depth filtration and perfusion technologies
· Assess and monitor culture performance through Viable cell density, metabolite and nutrient monitoring relating to cell culture performance and product quality.
· SME for bioreactor control strategies, e.g; DO, pH, feed, base CO2 etc.
· Expertise in the modes of operation of downstream processes such as Chromatography, Depth Filtration, Virus Filtration and Inactivation, UFDF and Bulk Drug Substance Filling
· Provide expertise for associated purification equipment and technologies.
· Lead the analytical monitoring on processes such as protein concentration, impurity monitoring and clearance (HCP, DNA etc) and the impact to product quality
· Provide expertise in column packing techniques and technical troubleshooting.
· Apply scientific/engineering principles to support process deviations and provide product impact assessments.
· Use Six sigma tools to lead root cause problem solving.
· Provide expertise in the design, commissioning and qualification of the new manufacturing facility at Dundalk; through to commercialisation, ensuring all necessary plans are executed and delivered on time.
· Provide technical knowledge in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process SME.
· Be the escalated point of contact when trouble shooting process issues during start-up, tech transfer activities and commercial operations.
· Work closely with the extended manufacturing team ensuring any actions and plans are clearly understood and accounted for in alignment with plant operations plans.
· Identify and lead process improvement projects and cost reduction projects and work cross functionally to prioritise projects/support demands from the Business Unit.
· Author APQR and process impact assessments to support investigation closure as applicable.
· Implement process CAPA’s and performance improvements, conduct investigation trending.
· Author or review, and approve process validation strategies, protocols and reports.
· Coaching fellow process engineer/scientist and manufacturing personnel to increase technical knowledge of critical process steps and develop plans to build competencies and expertise.
· Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate.
· Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
· Change Control write up, close out and approval as applicable.
· Participate in cross-functional project teams as applicable
· Maintain role as ‘Process Guardian’. Responsible for analysis of routine statistical process control charts and follow-up of trends flagged.
· Key technical SME participating in regulatory audits.
· Introduction, design and qualification of new or alternate single use technology consumables or raw materials.
· Work to implement a culture of Right-First Time through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimise technical and business processes.
· Support the disposition process. Ensure all data is ready in a timely fashion to support business unit disposition metric.
· Perform additional duties at the request of the direct manager.