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Senior Scientist - Analytical Development

Contract Type: Permanent
Location: Midlands
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie

Job Description

Senior Scientist - Analytical Development
My client a well-established multinational Healthcare provider are now seeking to add to their expanding Analytical Development group a Senior Scientist.
The successful candidate will develop a wide variety of chromatography, and other biological activity and process impurity assays for biologics drug candidates at all stages of development with a particular focus on critical program needs including CMC development for INDs and BLAs. An ideal candidate will have experience in drug development, including experience as a participant on CMC/Technical teams. A good scientific understanding of protein biophysical chemistry and activity assays is essential.
This is a permanent role based in The Midlands and is commutable from parts of Dublin and Galway.
Responsibilities of Senior Scientist - Analytical Development
  • Execution of relevant experiments to support development, qualification and optimisation of analytical assays for biologics in development
  • Develop a relevant tool box of qualitative and quantitative assays for process development as well as product characterization, including release assays to follow critical quality attributes
  • Understand CMC needs, deliverables, timelines, responsible for delivery of results and proactively plan work and resources for timely execution
  • Author and/or review key regulatory documents including IND and BLA sections collaboratively and as needed, laboratory data, technical memos and reports
  • Generation of analytical methods, qualification reports, results & share with collaborators; present data proactively and regularly in group meetings; communicate plans and results to collaborators and manager iteratively
  • Train and mentor colleagues and associates when needed
  • Engage the broader scientific community through poster and oral presentations at industry conferences and publications
Requirements of Senior Scientist - Analytical Development
  • BSc, MSc in biological sciences, preferably biochemistry, biophysical characterization of proteins.
  • 10 years of relevant experience in academia or in industry
  • Strong knowledge of protein chemistry, structure, and function. Familiar with common protein post-translational modifications and characterization methods
  • Experienced in method development of biochemical, LC-MS, and/or bioassay methods for characterization of proteins, qualification, and transfer
  • Experience with late-stage therapeutic protein characterization for BLA and regulatory document drafting preferred
  • Previous experiences with studies on antibody structure-function relationship with CQA assessment preferred
  • Experience in other advanced bioanalytical techniques, such as cIEF, CE-SDS, SEC-MALS, AUC, CD, particle analysis preferred and excellent assay troubleshooting skills. A working knowledge of Empower, Fusion, LIMS, Nugenesis, VMS and QDMS is highly desirable.
  • Excellent communication (oral and written) and interpersonal skills; ability to work well with a wide range of functional groups including R&D, QC, QA, Regulatory Affairs, and Commercial Operations
  • Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment
  • Understanding of ICH, USP, Ph Eur, FDA and relevant guidelines for CMC development; interest in developing CQAs
  • Good time and project management skills, and ability to work on several projects simultaneously. Good organizational and communication skills
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below