Technical Specialist- Upstream
This vacancy has now expired
The Technical Specialist will be part of the cell culture team to support the facility start-up and routine commercial manufacturing from small scale and large scale media preparation, vial thaw, through typical scale up processes, to seed and production bioreactors, with harvest and clarification technologies respectively.
The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification.
The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.
- To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup.
- Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.
- To author and review process supporting documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
- To 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.
- Partner with Operations to support protocol completion, execution and sample reconciliation.
- To generate documentation reports for plant supporting studies and technical studies on the manufacturing floor at commercial scale.
- May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution, as well as any other duties as required.
- To provide on the floor support for troubleshooting processing issues and to participate in closeout of manufacturing investigations into process deviations and resolution.
- Lead any key process changes using change control management system as required.
- Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
- Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
- Minimum 1-2 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 upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.
- Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.
- Understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
- Ability to present and defend technical and scientific approaches in both written and verbal form.
- Ability to drive for results independently and adapt to rapidly changing priorities.
- Detail orientated.
- Technical writing competency.
- Self-driven to do the right thing.
- Enjoy a fast paced working environment with broad levels of engagement and insight for self-development and experience gain in a startup environment.
If you have a background in Drug Substance/Mammalian cell product transfer or introduction or are a keen bio process Specialist and are keen to progress further in your career, please apply with your CV now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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