€40000 - €41000 per annum
Our client a leading Pharmaceutical Company in Kildare are currently recruiting for a Process Scientist to join their team. Be a key member of the team, working within the site Technical Services team to provide process technical support to the SSF facility and enable future cell culture process tech transfers and multi-product operations in the facility. Support process validation of the processes running in the SSF Facility. Support all associated filing submissions as well as working to ensure inspection readiness of the new processes and their validation.
- Support the on-time delivery of the Technical Services deliverables to support the SSF plan of record and new process introductions. This can include leading major investigations, writing filing responses, implementing changes to improve processing and productivity.
- Lead process tech transfer into SSF in line with company guidance.
- Process Definition (Description), including Bills of Materials, Raw Materials and Consumables
- Process Mass Balance & Flow Schematics
- Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment
- Oversee scale up & development of processes, as required, working with Manufacturing Science & Development (MSAT) and Engineering colleagues
- PFD/ (key process) P&ID approval
- Process input to equipment specification process, including equipment sizing, specification of key components (e.g. pumps, columns), verification documentation and process instrumentation ranges
- Oversee completion of Engineering/Demo batches
- Execute requisite process trials to facilitate transfer (bioreactor kLa studies, media/buffer make-up & hold, cleaning cycle development, column packing, preservative flush-out, media simulations, etc)
- Process validation execution and completion of summary reports
- Drafting of filing submissions
- Inspection readiness activities including preparation of playbooks.
- Act as liaison with MSAT to support the introduction of process improvements and flexible, multi-product manufacturing strategies.
- Support implementation of IMEX standard work practices to optimise the performance of the SSF Technical Services team.
The Ideal Candidate:
- Minimum of 2 - 5 years' experience working in a manufacturing process; process development or tech transfer environment
- Familiarity with the operation of cell culture (upstream or downstream) technology
- Knowledge of technology transfer
- Demonstrated aptitude for technical learning.
- Strong evidence of problem-solving skills
- Good communication skills
- A minimum of a B.Sc., B.E., or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with a large element of biotechnology in the curricular
For more information on this fantastic opportunity contact Orla Crowley
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.
This position was pPosted on 30 Aug 2021