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Lead Manufacturing Biotech Associate
2 months ago
This role will be part of Manufacturing Self Directed work team/ Hub in the new state of the art single use multi-product biotech facility. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
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The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.
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Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and provide a reliable supply to our customers.
Primary responsibilities include but not limited to:
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·       Carry out and support operations to achieve assigned duties.
·       Deliver shift standard work for a team-based approach to batch progression.
·       Complete COMMIT cards to highlight ways of working within our SDWTâs and Hubs and across our site that support our COMMIT culture.
·       Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
·       Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
·       Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
·       Provide coaching to the shift teams on the RFT approach to documentation.
·       Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
·       Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
·       Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
·       Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
·       Coach and provide oversight on the shop floor to identify potential issues before they arise.
·       Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.
·       Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
·       Lead straight-through document accuracy metrics and the development of a CI framework.
·       Support site functional initiatives to improve compliance status and operational efficiency of the site.
·       Run handover boards and provide key updates to shift leads for handover.
·       Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays.
·       Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
·       Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
·       Effectively manage and schedule equipment shutdowns.
·       Ensure resources are available, thereby minimizing downtime.
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Any other duties as and when assigned by the Manager. Such as act as a designee for Manufacturing Shift Lead as required.
Minimum Education/ Experience:
·       Bachelors Level 8 degree in science, engineering or other technical discipline, or a Level 7 qualification in a science or engineering discipline with a minimum of 5 yearsâ experience in a GMP regulated environment.
·       5 years experience in a regulated GMP environment.
·       3 years experience in Biopharma industry, with direct experience of biologics manufacture would be desirable.
·       Proven record of accomplishments in a regulated industry required.
