Role Title: Upstream/Downstream Manufacturing Support Scientist
Location: Dublin 15
We are currently working with a Biopharmaceutical Manufacturer in Dublin 15 who are seeking to recruit a contract Manufacturing Support Scientist/Engineer, reporting into the Associate Director for new product introduction within the Manufacturing group.
Responsibilities will include (but not limited to):
Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes.
Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing.
Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing.
Represent the Manufacturing at meeting to ensure the end user requirements are represented
Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches.
Identify process improvement projects for New Product Introduction and support projects to completion.
Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood.
Write process impact assessments to support new product introduction.Provide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation.
Provide training to BPAs on new procedures.
Support external and internal audits.
Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction.
Work to implement a “Right-First Time Culture” and provide leadership in the use of OE principles.
Support the disposition process when required
Carry out organizational activities such as purchasing & co-coordinating communication information.
Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety.
Minimize human error and work with operations to remove sources of error.
Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.
Support sustaining operations when required to ensure product supply
Develop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance.
Support and implement new technology solutions such as Single-Use technology.
Qualifications and Experience required:
3-4 years experience in Upstream or Downstream Manufacturing.
Bachelors/Masters in Science, Engineering, or a related subject.
In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation.
Proven ability to support the closeout of complex technical investigations.
Strong working knowledge of systems such as Delta V, MES Syncade and SAP.
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