My client a leading and rapidly expanding Pharmaceutical Company now require a Manufacturing Associate – Biologics to join their rapidly expanding team.
The Manufacturing Associate – Biologics is responsible for performing GMP manufacturing operations for a strategic cell therapy product in my client’s new regenerative medicines facility
This is a permanent role based in Dublin.
Responsibilities for Manufacturing Associate – Biologics
- Scope includes aseptic regenerative medicine manufacturing in a clean room environment including cell therapy products.
- Execute production activities: cell culture, cleaning, environmental monitoring, preparation of media and reagents according to cGMP for aseptic production and biological products.
- Complete daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs, and records of equipment and batches as required.
- Ensure timely completion of all SOP, reading, training and assessment.
- Ensure all processing equipment and materials necessary are available, maintained and qualified as required for the different manufacturing activities.
- Ensure the integrity and quality of the products produced in compliance with operating procedures to meet all cGMP, regulatory, and safety requirements.
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
- Support investigations in manufacturing and technical deviations.
- Drive the implementation of Standard Work amongst team ensuring activities are coordinated and integrated (training, documentation, process improvements, investigation activities etc.) using an inclusive planning system.
- Support achievement of overall operational readiness schedule adherence for the new regenerative medicines facility
- Other duties as required and directed by the Team Lead.
Requirements for Manufacturing Associate – Biologics
- Required: laboratory / pharmaceutical manufacturing experience
- Science, Engineering or BioChemistry Level 6 Qualification or other relevant field of expertise an advantage
- At least 1 years’ experience in pharmaceutical manufacturing in the field of aseptic manufacturing operations.
- Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
- Desirable: strong background in cell / tissue culture, preferably with mammalian cell lines (human or animal) and primary cell culture
- Detailed knowledge of aseptic manufacturing operations, as well as Quality and HSE. Familiar with EU GMP regulations specific to aseptic manufacturing.
- Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below