Lead Tech, Operations

Job Description A fantastic opportunity has arisen for a Lead Tech, Operations. Bring energy, knowledge, innovation to carry out the following: The Lead Manufacturing Bioprocess Associate will provide operational support for shop floor operations of the Late Stage and Launch Pipeline at our new state of the art single use biotechnology facility in Dunboyne.

The Lead Manufacturing Bioprocess Associate, is responsible for: Supports end-to end production, supporting production (Cell Expansion, Fermentation, Purification) for both Batch and Continuous Manufacturing. Operate equipment according to electronic batch records, sampling plans and standard operating procedures. Work as part of a dedicated process team where flexibility and teamwork are a key requirement. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Support weekend or on-call duty on select time frames to support manufacturing. Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.

The Lead Manufacturing Bioprocess Associate is also responsible for: Lead/Guide team members in a process team in one or more unit operations within BioNX. Work with Facility Management/internal team members in the maintaining of GMP status of responsible equipment devices in routine monitoring, calibration, maintenance, and certification.

What skills you will need: In order to excel in this role, you will more than likely have:

• Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
• 5 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
• Competent in troubleshooting and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Understanding of multi column chromatography concepts.
• Familiarity with contamination control and batch release requirements.
• Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
• Proficiency in various SingleUse techniques and experiences in the area of an end Single Use Facility.
• Commissioning and Qualification experience.
• Problem, Deviation, and Change Management experience.
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge some key unit operations.
• Understanding of both continuous and batch fed manufacturing processes.
• Familiarity with contamination control and batch release requirements.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company's first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company's research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Required Skills

• Aseptic Technique
• Biopharmaceutical Industry
• Coaching
• Good Manufacturing Practices (GMP)

Preferred Skills

Job Posting End Date: 08/16/2026

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): Yes