Analytical Scientist
Grange Castle - Dublin
Cpl in partnership with our client Pfizer are seeking an Analytical Scientist to join the team for an 11-month contingent fixed term contract at their state of the art site in Grange castle, Dublin. This is an onsite role.
Analytical Scientist
Working in a multidisciplinary analytical team you will contribute to the characterisation and analysis of therapeutic glycoproteins, mRNA and conjugate vaccines.
Your role will be to provide analytical characterisation, new method and technology development, and technical support to several functional groups including Protein and Vaccine Process
Development and pilot scale manufacturing operations, Commercial manufacturing, and the Quality and Regulatory units.
This is what you can look forward to:
·Become expert in the application and development of analytical methods used for the characterisation and manufacturing support of therapeutic proteins, vaccines and small molecules.
·Participate in cross-functional teams in support of late-stage development and commercial products.
·Provide technical subject matter expert and investigative support to commercial manufacturing operations.
·Participate in the technical writing and review of analytical documentation, and regulatory submissions and responses.
·Evaluate, develop and qualify analytical technologies to support method improvements for use in analytical development and QC laboratories.
·Provide analytical support to process development team in bench and pilot scale production of proteins and vaccines, including sample analysis and interpretation of results, as required.
What you offer
To be successful in this role you will require:
·B.Sc. / M.Sc. or higher qualification in analytical biochemistry, chemistry, biotechnology or a related discipline.
·3-5 years' experience in analytical role in pharmaceutical industry, experience with biological products and/or vaccines an advantage
·Technical capability in several major areas of analytical sciences such as: UPLC / HPLC (UV, FLR, CAD), MS, GC, spectrophotometry, bioassay, ELISA, FACS, wet chemistry techniques and capillary electrophoresis. Experience characterising glycoproteins, monoclonal antibodies and vaccines an advantage.
Independent contributions as a scientist through one or more of the following:
·Demonstration of problem-solving ability through independent contributions to analytical method development/qualification/validation programs.
·Lead role in analytical investigative support.
·Subject matter expertise in one or more analytical technologies.
·Ability to independently plan and perform work assignments, interpret and present data.
·Possession of technical problem-solving abilities and communication skills – accredited lean/six sigma/DMAIC competency is desirable.
·Capability of coordinating activities and delivering project goals working in a multi-disciplinary team environment.
·An understanding of industry specific standards/ regulations e.g. ICH, GMP, Environmental, Health and Safety etc.
·Demonstration of ability to interpret industry guidelines for execution of technology transfer and implementation of analytical method validations considered an advantage.
·Experience in authoring/contributing to analytical aspects of regulatory submissions and agency responses.