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Cell culture processing expert - biopharmaceuticals

Dublin
beBeeBiopharmaceutical
Culture
Posted: 14 July
Offer description

Job Title: Upstream Technical Services Specialist "> About This Opportunity This is an exciting role within a leading pharmaceutical organization that is dedicated to driving innovation and making a positive impact on people's lives. We are seeking an experienced Upstream Technical Services Specialist to join our team in Dublin, where you will have the opportunity to work on cutting-edge technology and contribute to the development of new medicines. The successful candidate will be responsible for providing technical support to our upstream manufacturing processes, including media preparation, large-scale cell culture bulk drug substance manufacturing, and process validation. You will also play a key role in authoring and reviewing process transfer documentation, gap assessments, and technical protocols. We are looking for a highly skilled and experienced professional with a strong background in biopharmaceutical manufacturing. The ideal candidate will have a minimum of 5 years' experience in a similar role and a comprehensive understanding of cGMP requirements. Responsibilities: 1. Provide technical support to upstream manufacturing processes, including media preparation and large-scale cell culture bulk drug substance manufacturing 2. Author and review process transfer documentation, gap assessments, and technical protocols 3. Liaise with Global Process Development to oversee the design and execution of laboratory studies 4. Support the introduction of new raw materials and consumables through the generation of materials lists and Bills of Materials 5. Work closely with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines Requirements: * Minimum 5 years' experience in Technical Services/Process Development/Manufacturing Support in a biological bulk drug substance manufacturing organization * Technical and operational knowledge of multiple unit operations in cell culture processing * Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing * Experience of Technology Transfer activities is advantageous Working Environment: This is an excellent opportunity to work in a dynamic and innovative environment, where you will have the chance to make a real difference in the field of biopharmaceutical manufacturing. Our organization offers a collaborative and supportive work environment, with a strong focus on employee development and well-being. Please note that this job description is not exhaustive and may be subject to change as required by the business.

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