Specialist - QC Separation Sciences

at  Amgen

Overview:
This job specification outlines the general responsibilities associated with the role of QC Separation Sciences - Technical Specialist at the Amgen Manufacturing site. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a role model for other lab colleagues. The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities

• 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

• 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 improvemen