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Associate Scientist

  • Location: Cork, Cork, Ireland
  • Type: Temporary
  • Job #22804

Associate Scientist

Location: Cork
Employment: 12-month contract  
Work Model: Hybrid
Visa sponsorship: No
Would you like to join one of the top 3 Pharma employers in the country and make your CV look even better? Here’s your chance!
Why is this a great role:

  • Work for a company that was voted one of the top employers in 2021.
  • You will join a friendly team of 5-10 so you will have many people to help you and support you if needed.
  • You will work hybrid with 3 days from the office and 2 days from home so you can take the best out of both worlds.
  • A short interview process with only 2 stages. We will not waste your time!

What will you do:  

  • Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to Annual Product Quality Review (APQR) for analysis and for driving process technology innovations.
  • Collect data for ongoing process verification, tracking and evaluation of product performance and implementation of Corrective and Preventive Actions (CAPAs).
  • Interpret complex technical challenges and provide resolutions to enable decisions.
  • Perform first line evaluation of product and process related issues (deviations, complaints, Out of specification (OOS), Out-of-Expectation (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 manufacturing (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 Good Manufacturing Practice (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
  • May be responsible for managing one or more associate scientists.

What will make you successful:

  • 3-5 years relevant experience in process development, manufacturing sciences or commercial manufacturing in a GMP environment
  • Bachelor’s degree in biochemistry, biotechnology, Bioprocess and Chemical Engineering – Technical expertise in upstream & downstream processes
  • Familiary with Trackwise, Oracle & laboratory information management systems
  • Periodic week-end laboratory work and week-end support work and/or on-call support for Manufacturing will be required.

Desirable:

  • Masters or PhD qualification in a relevant technical area would be an advantage
  • Experience working in Biopharma 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

SUBMIT YOUR CV TODAY!
Everyone will get a response
Please do not hesitate to contact any of our team with any questions you may have on Email: [email protected] or Phone: +353 1 6694040.
 

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