Scientist - Senior QC Analyst - Method Development - Amgen - Dublin


Location: Ireland

EUR 30 - 40 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

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 karen@jobcontax.com? 


Scientist - Senior QC Analyst - Method Development - Amgen - Dublin


Employer

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. 


Job Description

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. 


Requirements 

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


Package

Contract rate of €30 - €40 per hour

Minimum 12 month contract


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or call +353-1-7978720

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