Senior Process Scientist – Manufacturing Support | Collins McNicholas

Senior Process Scientist – Manufacturing Support

  • Reference: GJ42932y
  • Job Type: Permanent
  • Location: Clare, Galway, Limerick
  • Category: Science, Pharmaceutical & Food

Supports the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.


• Leads scientific process investigations with relevant departments as required.

• Leads and authors Process Validation protocols and report activities.

• Performs product impact assessments.

• Develops and writes protocols for manufacturing support activities.

• Serves as a subject matter expert (SME) for data trending and manufacturing support activities

• Presents findings at group and possibly at interdepartmental meetings

• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer

• Applies statistical process control tools in monitoring the manufacturing process.

• Investigates OOS and OOL IPCs

• Leads or Participates in process and quality risk assessments

• Presents process monitoring data to IOPS Management as necessary

• Assists in troubleshooting activities associated with the manufacturing process

• Supports technology transfer activities as needed

• Reviews and/or approves Manufacturing documentation associated with the transferred process.

Skills, Experience and Qualifications:

• PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years experience; may consider another discipline with added relevant experience.  cGMP experience is desirable.
• Candidates with an MSc Biotechnology or related field with 6+ years experience will also be considered. cGMP experience is desirable.

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Amy O’Neill

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  • Amy O’Neill
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  • 091706718
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