Job Title: MS&T Senior Bioprocess Engineer
An exciting opportunity has arisen for a highly skilled and experienced MS&T Senior Bioprocess Engineer to join our team at Dunboyne Biologics.
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Key Responsibilities:
* Participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.
* Develop strategies and execute technology transfer, process, and clean validation programs in line with company, industry, and regulatory standards.
* Act as a process Subject Matter Expert, supporting process investigations and using risk management techniques to assess strategies and prioritize activities.
* Lead significant business-critical projects associated with new product introduction and site capability build.
* Act as system owner and Subject Matter Expert, supporting investigations and prioritizing activities using risk management techniques.
* Ongoing optimization of process equipment and development of future breakthrough business solutions.
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Requirements:
* Minimum 6 years of experience in a biologics drug substance environment.
* Technical expertise in biological drug substance upstream and/or downstream purification unit operations.
* Experience in technology transfers for clinical or commercial biologics.
* Experience with automated systems.
* Process validation and cleaning validation experience.
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Qualifications:
* Minimum of a Bachelor's Level 8 degree in a technical field (e.g., Engineering, Science, or equivalent).
* Experience in the biotechnology or pharmaceutical industry.
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Skills:
* Technology Transfer
* Process Investigations
* Upstream and Downstream Purification Unit Operations