·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 Upstream
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 e.g. deviation, change controls, Corrective Action & Preventive Actions, working
effectively in cross-functional 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 continuously working with other relevant (including global) Subject Matter Experts 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) 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 Upstream Operations, gained through on the job experience in either process development or
manufacturing operations.
·Significant biotech industry experience in process development and process scale up manufacturing.
·Has experience in Upstream 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 continuous