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Process Manager - Data Monitoring

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 21/03/2018
  • Job reference: J383668A

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Process Manager - Data Monitoring

A Process Manager - Data Monitor is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for supporting the Process Monitoring team through leading the area of process performance monitoring. This role will also be responsible for establishing, organizing, and maintaining the In-Process Controls process performance monitoring program and supporting manufacturing activities. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.

Responsibilities:

* Lead the team that champions the process performance monitoring program, and manage all activities to assure that manufacturing processes are supported
* Manages routine process monitoring activities including data entry, statistical analysis, cross-functional data review and issuance of trend reports and plans
* Responsible for ensuring verified process data is available and easily accessible.
* Apply statistical process control to clinical and commercial process data to enable decision making
* Presents and reviews process performance monitoring data to IOPS Management as necessary
* Work with cross-functional departments to ensure process data is being used to maximize process understanding and knowledge sharing initiatives
* Ensures compliance with regulations and regulatory guidance
* Develops, coaches, and provides leadership within the process monitoring team.
* Assists in troubleshooting activities associated with the manufacturing process that involves data analysis
* Ensure information requests for data from the IOPS site is provided in an accurate, complete, and timely manner
* Involve the correct subject matter experts (SMEs) to answer detailed information requests and help troubleshoot unexpected process performance


Education/Experience:

  • Requires a BS/MS in a related field (Biotech/Pharma/Chemistry preferred)
  • 5-10 years of relevant industry experience and previous supervisory experience
  • Equivalent combination of advanced education and experience may be considered
  • Ideal candidate has experience in biologics drug substance (DS) manufacturing and technology transfer

Skills/Competencies:

  • Knowledge and application of statistical techniques for process control
  • Excellent analytical skills with an orientation to detail; experience in distilling critical qualitative and quantitative information from complex data to inform programme performance, learning and quality improvements
  • Excellent time management, organizational, written and verbal communication skills
  • Represent a professional, respectful, and ethical manner when interacting with co-workers and internal/external parties
  • Proven experience in supervising of programme teams to ensure the programme reporting work flow requirements are met
  • Excellent interpersonal and communication skills; able to make complex data simple, able to communicate effectively with youth, work colleagues and high-level audiences
  • Sound understanding of the programme management cycle and support activities


For more information on this and similar position please contact Jack on 01 6455252 or email jack.conway-kenny at experis.ie

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