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MSAT Frontline Scientist/Engineer

Manufacturing / Production
Cork
Sharmini Yapan
Temporary
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Job Reference: JO-2211-66347_1673522942

Summary:

The MSAT Frontline Scientist/Engineer reports to the GMSAT Biologics Centre of Excellence Frontline Manager and is responsible for being the primary contact with Manufacturing for a given product prior to, during and post-campaign. Their primary role is to ensure that the manufacturing process performs as expected while ensuring continuous process improvement through the application of scientific and engineering expertise.

Responsibilities:

  • Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
  • Collect data for ongoing process verification, tracking and evaluation of product performance and implementation of CAPAs.
  • Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
  • Work closely with the other GMSAT Team members, be engaged in the planning of experiments resulting from campaign learnings to increase process robustness and reduce Cost of Goods Sold (COGS)

Requirements :

  • Bachelor's degree in biochemistry, biotechnology, Bioprocess and Chemical Engineering or similar with 3-5 years relevant experience in process development, manufacturing sciences or commercial manufacturing.
  • Masters or PhD qualification in a relevant technical area would be an advantage.
  • Experience working within a regulated or pharmaceutical environment would be desirable.
  • An interest in Advanced Data Analytics and Design of Experiments with experience in RStudio, SAS, JMP,Oracle, Trackwise, SIMCA, Excel, Discoverant etc would be desirable.

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