Biochemistry Expert for Pharmaceutical Industry
3 days ago
Company Overview
CPL, in partnership with our client Pfizer, are seeking an analytical biochemist to join their team for a fixed-term contract at their state-of-the-art site. This is a laboratory-based role.
Job Description
We are currently recruiting for analytical scientists based in our Grange Castle Site. This is an exciting opportunity to join the Pfizer Ireland Pharmaceuticals manufacturing plant, situated on a 90-acre site in South Dublin. Our site features state-of-the-art technology & production expertise, resulting in the production of quality-driven products that improve people's lives around the world.
Role Description:
- Provide analytical characterisation, 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.
Required Skills and Qualifications
- Provide analytical support to process development for bench and pilot scale production of protein and vaccine therapeutics, including sample analysis and interpretation of results.
- Provide investigative support to commercial manufacturing operations.
- Become expert in the application and development of analytical methods used for the characterisation and manufacturing support of therapeutic proteins and vaccines.
- Participate in the technical writing and review of analytical documentation, and regulatory submissions and responses.
- Participate in cross-functional teams in support of late-stage development and commercial products.
- Evaluate, develop, and qualify analytical technology platforms to support method improvements for use in analytical development and QC laboratories.
Education/Experience:
- B.Sc. / M.Sc. or higher qualification in analytical biochemistry, chemistry, biotechnology, molecular biology, or a related discipline.
- Technical capability in several major areas of analytical sciences such as: HPLC, GC, wet chemistry, molecular biology techniques (PCR, Western blots etc), mammalian cell culture, spectrophotometry, capillary electrophoresis. Experience analysing proteins and peptides by mass spectrometry (LC-MS) an advantage.
- Experience in biopharmaceutical or pharmaceutical industry with independent contributions as an analytical scientist through one or more of the following:
- Demonstration of problem-solving ability through independent contributions to analytical method development programs.
- Lead role in analytical investigative support.
- Subject matter expert 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.
- Capable of working in a multi-disciplinary team environment.
- An understanding of industry-specific standards/ regulations eg ICH, GMP, Environmental, Health and Safety etc.
- Demonstration of ability to interpret regulatory guidelines for execution of technology transfer and implementation of analytical method validations considered an advantage.
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