Specialist - QC Separation Sciences

Amgen Inc.

3.6

(9)

Dublin, Ireland

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-205620

    Position summary

    ilities
    • SME in a variety of analytical techniques including but not limited to HPLC, HIC, CE, UPLC and Mass Spectroscopy
    • Plan and perform multiple, complex routine/ non-routine methods
    • Responsible for providing technical guidance and applying expertise and critical thinking to independently resolve technical issues
    • Lead training of staff on technical aspects of job as required
    • Develop, revise and implement procedures that comply with appropriate regulatory requirements
    • Experience of managing project groups and leading high performing teams and delivering results
    • Qualification of analytical equipment and related testing functions
    • Co-ordinates & plans activities related to the successful method transfers and optimisation of Separation Methods into the Amgen site
    • Compliance with Standard Operating Procedures and Registered specifications
    • Ensure the laboratory is operated in a safe manner
    • Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
    • Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures
    • Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing
    • Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
    • Participate in regulatory agency inspections as required
    • Plan and implement procedures and systems to maximise operating efficiency
    • Manage and contribute to the achievements of department productivity and quality goals
    • Act as a change agent in support of continuous improvement

    Basic Qualifications:

    • Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
    • 7+ years of experience in a pharmaceutical/healthcare Laboratory
    • Proven experience of leading teams
    • Strong background in Separation techniques e.g. HPLC, CE and Gel Electrophoresis
    • UPLC and Mass Spectroscopy experience advantageous
    • Analytical Technical Transfer experience essential
    • Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating

    Preferred Qualifications:

    • Excellent written and verbal communication skills
    • Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
    • Knowledge of applicable Regulatory requirements
    • Experience with Regulatory inspections and interacting with inspectors
    • Experience leading cross-functional teams
    • Experience working with teams and influencing decision making
    • Skilled in the use of problem solving tools/techniques

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging