Job Type: Contract
Job ID: JO-1901-12498
Consultant: Karen McHugh
Are you a Senior QC Analyst with Aseptic drug product experience in the biotech/pharma sector?
Have you experience with analytical method development in association with Mass Spectrometers & Karl Fisher Titration?
If you would like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development, send your CV to firstname.lastname@example.org?
Scientist - Senior QC Analyst - Method Development - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Seeking a highly motivated individual to function as a member of a commercial drug product team.
The successful candidate will report to the Scientific Director and provide drug product support to process characterization and commercial manufacturing team.
Position will perform experiments, organise data and analyse results with minimal supervision.
Evaluation of product impact due to process variables will be a critical deliverables for this role.
Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods is a need for this role.
The position will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate data to the cross functional group.
Cross functional teamwork will be a critical component of this job.
Regular interactions with Quality and Regulatory functions are expectations for this role.
Effective communication skill is a requirement with the ability to exert influence a plus for this role.
University degree gained in Chemistry, Biology or Science related discipline.
Significant experience gained within the pharmaceutical or biotechnology industry.
Experience to include understanding of physical / chemical stability of proteins, and interpreting results from various analytical methods on proteins.
Process characterisation, scale-up, and/or technology transfer experience.
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.
Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing.
Excellent written and verbal communication skills
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Operational Excellence experience desirable
Experience leading cross-functional teams desirable
Experience utilizing Lean principles and a risk-based approach desirable
Experience working with teams and influencing decisions
Contract rate of €30 - €40 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or call +353-1-7978720
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