Purification Process Scientist

PE Global are currently recruiting for a Downstream Purification Process Scientist on behalf of our client based in West Dublin –

This is an ideal development opportunity to join a dynamic team who provide process science support to the ongoing requirements of the manufacturing area. The purification process scientist is responsible for providing technical support to the operating unit ensuring that the purification processes are robust, appropriately validated and run so as to maintain that validated state. This role focuses on process monitoring and troubleshooting, including leading and resolving technical issues and process investigations, yield improvements, implementation of cost reduction projects, and support process transfer projects including facility and equipment design specification.

The downstream purification process scientist works with the Technical Services teams to deliver integrated technical services to meet the site business objectives. The role requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.

Job Responsibilities:

• This is a non-laboratory based role, providing downstream purification SME support to the protein drug substance manufacturing facility;
• Support major investigations, including preparation of process impact assessments;
• Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends;
• Support introduction of new raw materials or consumables and assessment of Supplier Change Notifications (SCN’s);
• Execute Annual Product Quality Reports (APQR) and process capability analysis on commercial processes, on a periodic basis;
• Implementation of process improvements in the purification areas (yield / robustness / cycle time / cost reduction);
• Process validation execution in support of major process changes;
• Strong understanding of 6-sigma principles and data analytics;
• Regulatory inspection support and close-out of regulatory follow-up measures;
• Technology transfer of new processes or process changes;
• Process equipment design, including development of user requirement spec;
• Introduction of new technology, including process analytical technology (PAT).

Qualifications / Experience:

• Minimum qualification of a B.Sc./M.Sc. or higher qualification in chemistry, biotechnology or a related discipline;
• Minimum of 3 years in a GMP manufacturing environment within a regulated pharmaceutical industry, ideally in the Biopharmaceutical industry;
• Strong background or experience in protein purification including chromatography and ultrafiltration is a requirement

Skills:

• Demonstrated technical capability and aptitude for technical learning;
• Strong evidence of problem-solving/trouble-shooting skills;
• Ability to independently plan and perform work assignments, interpret and present data;
• Strong interpersonal skills with an ability to work independently across sites and teams;
• Highly motivated, proactive and persistent;

Interested candidates should send their CV to audrey.mccarthy@peglobal.net or call 0214297900