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Senior Scientist - Downstream MS&T

Senior Scientist - Downstream MS&T


Senior Scientist – Downstream MS&T
 
Are you a Scientist with experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry? Are you looking for your next big career move?  If you are interested in a fantastic opportunity working at an amazing company then keep reading!
 
This is a one-of-a-kind job with a world class biopharmaceutical leader
 
This is a permanent role based in Dublin.
 
 
What will you do in this job?
  • Independently lead the design and execution of experiments with a demonstrated ability to interpret data in protein chromatography, viral inactivation, ultrafiltration/diafiltration, and filtration unit operations to support New Product Introduction, Process Characterisation, Optimisation and site operations.
  • Matrix management of projects/activities within the team, prioritise and co-ordinate activities to ensure timely delivery.
  • Troubleshooting of manufacturing process-related events and evaluation of new process technologies through the design of scale-down studies and the evaluation of data from manufacturing. 
  • Contribute to and/or lead cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for facility fit activities, specification changes, technical assessments, alternate vendor qualifications, change management.
  • Strong knowledge of cGMP compliance, site and regulatory agency requirements.
  • Provide process subject matter expertise for regulatory inspections, filings and other interactions with regulatory agencies.
  • Contribute to and/or leads global network initiatives such as the evaluation of new technologies or the establishment of best practice approaches in area of responsibility
 
 
What do you need to be successful in this job?
  • Minimum BSc or equivalent with a minimum 6-9 years relevant experience, MSc or equivalent with minimum of 4-6 years relevant experience, Ph.D. with 2-4 years relevant experience, biological sciences or chemical/biochemical engineering.
  • Experience in designing and running studies in Downstream (protein chromatography, viral inactivation, ultrafiltration/diafiltration, and filtration)
  • Experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry.
  • Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
  • Experience with regulatory authoring (e.g. submissions, health authority responses) would be an advantage
  • Proven project/matrix management skills, including leading cross functional teams and balancing project assignments.
  • Troubleshooting issues in manufacturing, hands on experience
  • Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
 
 
What's in it for you?
  • A competitive salary with incentives/bonus.
 
And… much more!
 
 
The Next Step for you:
 
Interested in this role? Please send your CV to GILLIAN DUNPHY at Next Generation Recruitment by clicking on the Apply button!
 
Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.
 
Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.
 
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