Senior Chemist

Dublin  ‐ Onsite
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Description

A global healthcare company is currently seeking a Senior Chemist to work in their new site in Dublin . It is an exciting growth phase for this organisation and there is significant expansion plans. The scale of expansion and investment is extremely significant. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact. You will get great exposure to cutting edge systems and will get to see the product right through to market.

Day to Day:
  • Work with cross functional teams within the company to provide analytical support for all product development activities supporting regulatory submission and product commercialization.
  • Analytical SME who works with the product development and technical transfer groups to design experiments, perform analytical testing and interpret analytical results in line with protocol objectives
  • Work with the stability group within the company to design and execute stability protocols that meet regulatory requirements to support shelf life assignment for clinical studies and commercial product.
  • Perform analytical investigations and participate in laboratory and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results.
  • Compilation of technical documentation including test methods , protocols and reports to support regulatory submission, product and process understanding and technical transfer activities
  • Identify gaps in product and process understanding and contribute to design of DOE to build on product knowledge.
  • Review and approval of analytical data in line with study objectives


Requirements:
  • 4+ years' experience in an analytical role within the pharmaceutical sector in a FDA or IMB accredited laboratory
  • Ability to provide analytical and technical expertise to support product development and submission activities
  • Ability to take ownership and execute analytical studies with minimum supervision
  • Strong Technical writing skills with respect to protocol/report writing, batch record and SOP writing
  • Experience of root cause analysis/investigations and problem solving to support analytical investigations
  • Experienced in interpretation of analytical data
  • An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals.
  • Desirable qualification for this position are:Knowledge and Experience in Inhalation testing.


To hear more about the role and company please contact me Anna Mooney or apply below with an up to date CV.
Start date
06/2015
From
Real Staffing
Published at
17.10.2015
Project ID:
1002299
Contract type
Permanent
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