Amgen QC BioAnalytical Sciences Technical Specialist in Dun Laoghaire, Ireland
QC BioAnalytical Sciences: Technical Specialist
Amgen Dun Laoghaire - Dublin
This job specification outlines the general responsibilities associated with the role of QC BioAnalytical Sciences - Technical Specialist on 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.
Expert in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
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 BioAnalytical 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.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
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.
Skilled in the use of problem solving tools/techniques
Knowledge and Experience:
Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
Have 7 years of experience in a pharmaceutical/healthcare Laboratory.
Proven experience of leading teams.
Strong background in Bioassays, Immunoassays and Cell Culture is essential.
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.