I am seeking to recruit a Senior Scientist/Senior QC Bioanalytical Analyst with a strong background and hands-on experience in bioanalytical methods such as HPLC, Size Exclusion Chromatography, UV-Vis, Protein Characterisation such as peptide mapping, ICE and UPLC and compendial methods.
The successful candidate will take a role in defining new scientific approaches, data analysis, facilitate method transfers and method qualifications and validations.
Critical thinking, trouble-shooting and attention to detail is a must.
Duties/Responsibilities:
Provide technical oversight and ownership of analytical methods.
This includes partnering with analytical development to ensure method readiness for validation, assisting with validation protocols, gathering data generated by analytical development/QC labs and assisting with validation reports.
Lead complex projects and lead a team of scientists to meet deadlines and collaborate with key stakeholder groups.
Provide technical oversight of method revisions.
Lead method transfers to QC GMP labs.
Assist in obtaining critical reagent supply for assigned methods.
Provide expert input during periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods.
Review method summaries in regulatory filings.
Assist with Health Authority queries regarding analytical methods.
Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment
Qualifications & Experience:
Demonstrated trouble shooting and hands on experience with protein separation methods, for example, CE_SDS or ICIEF Electrophoresis, HPLC and UPLC Chromatography including Size-Exclusion chromatography, ion exchange and UVIS spectroscopy based technologies.
Good understanding of the fundamentals of protein characterization methods such as peptide mapping, and carbohydrate analysis.
Pharmaceutical sciences or bio-analytical related degrees or experience is desirable.
A BS with 10+ years or MS/PhD with 5+ years is desirable.
Strong written and communication skills and experience working in a matrix organization.
Experience leading complex projects, projects teams and meeting tight deadlines
Demonstrated critical based thinking skills and good organizational and presentation skills
Experience of method validation and transfer is desired.
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