Downstream Process Scientist/Engineer / Ireland

Downstream Process Scientist/Engineer

Attractive Salary – including Bonus and Attractive pension scheme

Dundalk


The Downstream Process Scientist/Engineer will provide technical expertise to support of the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. The role will ensure on-going optimisation of the Downstream process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic products.

The successful candidate will have the ability to support tech transfer activities for new products, on-going optimisation/continuous improvement of the downstream process, trouble-shooting downstream unit operations and leading major process investigations at the request of the business.

Essential Duties and Responsibilities:

• Strong understanding and experience with the modes of operation in downstream processing such as Chromatography, Column pack, Depth Filtration, Virus Filtration, and Inactivation, UFDF and Bulk Drug Substance Filling.
• Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements for Chromatography, VI, VF, Int. DF, UFDF and Bulk Fill.
• Provide expertise during the design, commissioning, and qualification of the new manufacturing facility at Dundalk through to commercialisation, ensuring all necessary plans are executed and delivered on time.
• Serve as a downstream subject matter expert during the establishment of the commercial process, as well as routine manufacturing.
• Subject Matter Expert (SME) for trouble shooting process issues during start-up, tech transfer activities and commercial operations.
• Capable of applying scientific/engineering principles to support process deviations and deliver product impact assessments.
• Use Six sigma tools to perform root cause problem solving.

 

You will need:

• 5+ years exp in the biopharma industry, of which 3+ years exp should be as a downstream process scientist or process engineer
• Expert knowledge of Downstream Processes and current Good Manufacturing Practices (cGMP)
• Excellent focus and attention to detail.
• Strong experience of recipe design, creation and troubleshooting of downstream processes
• Exposure to, and use of, automation systems such as Unicorn and DeltaV (or similar) is desirable
• Demonstrated competencies in Chromatography, Column pack, Depth Filtration, Virus Filtration and Inactivation, UFDF and Bulk Drug Substance Filling is desirable
• Experience in tech transfer is a key advantage in this role
• Strong exposure to process validation is advantageous
• Excellent communication skills including computer literacy and ability to work independently and in team
• Third level qualification in a Science or Engineering related subject is essential

Please apply ASAP for immediate consideration.