·Represents Manufacturing Science and Technology within multiple customer product project teams using a
standard methodology/procedure to successfully transfer both defined as well as complex process stages into downstream operations, from development through to current Good Manufacturing Practice manufacturing. Be accountable for the
identification & introduction of new raw materials for pilot and production scale batches, work cross-functionally to
ensure relevant transfer and communication of critical process and technical information such that projects meet the
required deadlines/customer outcomes. Actively communicate with the customer via both face-to-face meeting and telecoms.
·Accountable for on plant technical support, process monitoring/training of required critical unit operations and off
line completion of Quality systems eg. deviation, change controls, Corrective Action & Preventive Action’s, working
effectively in crossfunctional teams to deliver improvements to deadlines. Experts in process data analysis.
·Contributes to the resolution of identified manufacturing process issues through leading RCA procedures to ensure
continuous improvements are made to the current Good Manufacturing Practice process. Act as Subject Matter Experts
within the site whilst Will continuously working with other relvant (including global) Subject Matter Expert’s to
develop knowledge base and deeper process understanding and also support as needed junior level team members on
specific technical problem resolution.
·Proactively anticipates and evaluates technical challenges within area of expertise and is self-managed in resolving
deviations, or changes to unit operations, including interaction and strong communication with both internal and
external team(s) resources to achieve successful outcomes and to facilitate continual learning through experience and
shared learning. Understand new technologies and how they may be applicable to process innovation.
Key requirements:
·Bachelor/Master in Biological science or biochemical engineering disciplines.
·Has knowledge in Downstream Operations, gained through on the job experience in either from laboratory process
development or a manufacturing operations back ground.
·Significant biotech industry experience/ Doctor of Philosophy in process development and process scale up
manufacturing.
·Has experience in Downstream operations preferably in a current Good Manufacturing Practice environment.
·Good interpersonal skills with ability to work cross functionally both with internal and external customers. Experience in working in cross functional project management and technical transfer activities.
·Proven problem solver and multi -tasking individual with track record of implementing improvements, has a good
technical attention to detail, communication skills both written and verbal, interpersonal qualities with a