Downstream Process Scientist
Reporting into the Manufacturing Technology (MT) Associate Director, the Downstream Process Scientist/Engineer will be responsible for ensuring that manufacturing processes are validated and maintained within their validated states.
The Downstream Process Scientist/Engineer will provide technical expertise to support of the commercial manufacturing of theurapeutic proteins in a mammalian cell culture facility.
The role will ensure on-going optimisation of the Downstream process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic products.
The successful candidate will have the ability to support tech transfer activities for new products, on-going optimisation/continuous improvement of the downstream process, trouble-shooting downstream unit operations and leading major process investigations at the request of the business.
This role will also have responsibility for the delivery of process excellence and reliability across all areas of the manufacturing process. The Downstream Process Scientist/Engineer will provide expertise to ensure the facility design and sustained activities meet end user requirements.
- Strong understanding and experience with the modes of operation in downstream processing such as Chromatography, Column pack, Depth Filtration, Virus Filtration and Inactivation, UFDF and Bulk Drug Substance Filling.
- Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements for Chromatography, VI, VF, Int. DF, UFDF and Bulk Fill.
- Provide expertise during 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.
- Serve as a downstream subject matter expert during the establishment of the commercial process, as well as routine manufacturing.
- Subject Matter Expert (SME) for trouble shooting process issues during start-up, tech transfer activities and commercial operations.
- Capable of applying scientific/engineering principles to support process deviations and deliver product impact assessments.
- Use Six sigma tools to perform root cause problem solving.
- The DS Process Scientist/engineer will work closely with the extended manufacturing team, ensuring all activites are clearly accounted for and carried out in alignment with plant operations plans.
- Identify and implement process improvement projects and cost reduction projects and work cross functionally to prioritise projects/support demands from the Business Unit.
- Write APQR and process impact assessments to support investigation closure as applicable.
- Implement process CAPA's and performance improvements, conduct investigation trending as required.
- Author process validation strategies, protocols and reports.
- Coach manufacturing personnel to increase technical knowledge of critical process steps and develops 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 and close out
- Participate in cross-functional project teams as applicable
- Maintain role as 'Process Guardian'. Responsible for the analysis of routine statistical process control charts and follow-up of trends flagged.
- Support regulatory audits.
- Introduction of new or alternate single use consumables or raw materials
- Optimising re-use of filters and columns gels, sampling plans and consumable usage.
- Work to implement a culture of Right First Time by partnering 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 ready in timely fashion in support of business unit disposition metric.
- Perform additional duties at the request of the direct manager
- 5 years' experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
- Self-starter and self-motivated; organized with good attention to detail
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Collaborative and inclusive approach to work and colleagues
- Previous experience managing and leading a small team would be advantageous.
- Experience of recipe design, creation and troubleshooting of downstream processes
- Exposure to, and use of, automation systems such as Unicorn and DeltaV (or similar) is desirable
- Demonstrated competencies in Chromatography, Column pack, Depth Filtration, Virus Filtration and Inactivation, UFDF and Bulk Drug Substance Filling is desirable
- Experience in tech transfer is a key advantage in this role