LSC have a requirement for a Technical Services Scientist/Engineer for our biotech client based in Athlone. As the Technical Services Scientist/Engineer you will provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products.
Responsiblities will include:
o Support technology transfers of new products into the the Facility
o Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
o SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
o Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
o Technical review of change controls for impact to product quality, safety and efficacy.
o Provide on-floor technical support and troubleshooting.
o Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
You will have the following qualifications/experience:
o Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
o Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
o Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
o Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
o Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
For full details on this role please contact Kathy at 021 4777329 or apply directly through this advert.