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Job Opportunity

Job Opportunity
QC Separations Associate Scientist
Mar 30, 2021
QC Separations Associate Scientist
Ireland Dundalk
Dundalk, Ireland
major responsibilities:

Job Summary

Reporting to the QC Separation Lead- Associate Director/Senior Scientist, the QC Separation Associate Scientist will be part of various technical projects/activities in the QC Separation  group of WuXi Biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project, the role will evolve based on project timelines, and may require candidates to carry out additional job functions not described in the job description but associated with the role.

 

Essential Duties and Responsibilities

  • Participate in QC Separation GMP Lab set up, including lab design, construction and commissioning of the new facility for production of biologics drug substance.
  • Perform analytical method transfer, verification/validation and routine analysis using various analytical techniques; including but not limited to HPLC, CE, cIEF and UV.
  • Support activities including general lab readiness, audit readiness, laboratory equipment qualification, routine calibration and maintenance.
  • Identify and prepare required GMP documents such as SOPs, protocols, methods and reports.
  • Drive the establishment of required inventory for Separation team and develop a system for stock control of laboratory consumables and reagents.
  • Foster Operation Excellence and continuous improvement environment; including implementing Lean tools (5S, Kanban and Kaizen).
  • Participate in Lab risk assessment, including Quality risk assessment and EHS risk assessment.
  • Maintaining high Quality, Compliance and Safety system in a Drug Substance GMP Laboratory.
  • Participate in various Lab deviation and investigation process such as OOS, OOT and non-conformance, including the implementation of CAPAs and change control.
  • General laboratory support such as housekeeping, and training support.
  • Consistently delivering and monitoring specific Lab Key Performance Indicators.
  • Other related duties assigned by management.

 


qualifications requirements:

Person Specification

 

Technical Competencies

  • Experience or knowledge of general Quality Control function and activities.
  • Possess knowledge of routine and non-routine QC/in-process testing.
  • Experience working in a QC Chemistry Laboratory is desirable.

Experience

  • Experience working in a Quality Control Lab or relevant GMP environment.
  • Previous experience from Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid/Ion Chromatography, Electrophoresis and Spectroscopy.
  • Experience with Empower and LIMs or related system is required.
  • Experience with Microsoft Word, Excel, and Powerpoint is required

Knowledge

  • Knowledgeable of regulatory bodies, FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus.
  • General knowledge of Biologics Drug Substance.

Qualifications

  • University degree in related science/quality discipline required

Behavioural Competencies

  • Ability to work in a team environment and independently.
  • Excellent interpersonal, verbal, and written communication skills
  • Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
  • Ability to think critically and demonstrate troubleshooting and problem solving skills.

Other requirements

  • < 5%Travel may be required for this position as directed by departmental management.
  • This is a shift based position

 

WuXi Biologics is an Equal Opportunities Employer

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