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.
- Ability to work independently.
