MSAT Scientist

  • Contract
  • Cork

Website Ref:TPM04705

Summary:
A biopharmaceutical company in Cork is looking for a MSAT Scientist to join their team. The incumbent will ensure that the manufacturing process performs as expected while ensuring continuous process improvement through the application of scientific and engineering expertise. This role will require technical understanding in cell culture and/or protein purification science and technology.

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.
  • Interpret complex technical challenges and provide resolutions to enable decisions.
  • Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
  • Lead and provide constructive challenge during process investigations and steer investigations to be data driven, risk-based and comprehensive.
  • Support Process Steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
  • Support process optimization establishment and new technology introduction for continued quality, capability and productivity improvements as appropriate.
  • Provide technical input to technology transfer related documents (e.g. clinical and commercial protocols, batch records, PV documents, equipment user requirements).
  • Prioritize effectively and manage multiple priorities in a fast-pace work environment.
  • 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).
  • Ensure process training is provided to MFG operations staff on a campaign basis.
  • Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up, facility fit and technology transfer.
  • Provide training for new personnel on the process and prior to each campaign.
  • Provide technical direction in troubleshooting and optimizing ongoing manufacturing upstream/downstream unit operations.
  • Monitor production process and trends and lead the analysis and communication of the results.
  • Provide manufacturing with critical information necessary for maintaining consistent product supply, now and in the future.
  • Lead/participate in the diagnosis and resolution of production problems.
  • Provide technical input to process validation plans, protocols and reports.
  • As the technical SME provide technical expertise and discussion during GMP audits from regulatory authorities.
  • Interface with Manufacturing, Quality and Validation, Quality Control, Process Sciences and Engineering.
  • Adhere to all site safety, environmental and industrial hygiene procedures and practices, and actively participate in maintaining and enhancing the safety of the workplace and the laboratories.
  • May be required to work periodically out of normal business hours.

Qualifications & Experience:

  • Bachelor’s degree in biochemistry, biotechnology, Bioprocess and Chemical Engineering.
  • 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 etc would be desirable.
  • MSAT.
  • Manufacturing.
  • Process Development.
  • Quality Control.
  • Analytical Chemistry.
  • Quality and Validation.
  • Facilities Services.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.