Senior Manufacturing Biotech Associate

Senior Manufacturing Biotech Associate

For major BioPharmaceutical company based in Dunboyne.

24×7 shift role

The BTA is responsible for manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include executing automated recipes using paperless technology to progress drug substance through inoculation and cell-culture activities, followed by filtration and purification in a state-of-the-art, single-use-technology facility. The role includes setting up single-use equipment between runs and performing production activities in line with world-class GMP and EHS standards. The BTA also drives optimisation and continuous improvement through standard work and Lean processing techniques, supporting the operations team to consistently deliver key performance indicators (KPIs).

• Support and execution of end-to end production operations
• Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
• Conduct all work activities with a strict adherence to the safety and compliance culture on site.
• Use Lean Six Sigma tools to support continuous improvement (CI) projects that increase agility and flow, improve throughput, and reduce cycle time and inventory.
• Support the operations team to consistently deliver key performance indicators (KPIs), e.g., EHS metrics, production plan, overall equipment effectiveness (OEE), compliance and training.
• Ensure all assigned manufacturing documentation tasks are completed in accordance with GMP requirements.
• Work as part of a dedicated process team where flexibility and teamwork are key requirements.
• Create and update SOPs and work instructions (WIs) to ensure compliance with regulatory standards.
• Participate in shift handovers and tier meetings, raising concerns promptly and proposing options for resolution.

Coach shift teams related to RFT documentation.

• Lead by example through coaching and mentoring on Merck Production systems (MPSs) skill transfer.
• Coach CAPAs, Change actions/ SOP updates, training module development/revision related to cell area
• Troubleshoot and resolve issues and delays
• Leads and participates in investigations arising from manufacturing documentation aspects when required.
• Promote EHS leadership behaviours
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
• Confirms that all activities have been correctly completed by the end of shift such as Real-time batch record/ SAP Comet review and elogs review.

Level 7 qualification in a science or engineering discipline desired.

A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing environment shall be deemed equivalent.

• High degree of problem-solving ability and adherence to scheduled timelines.
• A proven ability to lead cross functional teams and deliver on tight timelines
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
• Experience with contamination control and batch release requirements.
• Experience with single-use technologies in a manufacturing environment.
• Experience of upstream and downstream unit operations for mAb manufacturing.
• This role involves shift work on a 24/7 basis.

Preferred Experience and Skills:

GMP manufacturing experience.

Experience with systems such as SAP, Emerson Delta V and MES (PAS-X), and the use of automation in a manufacturing process.