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Post : Scientist III, Bioanalytical
Job Description
This is a hands-on, non-supervisory position in which the incumbent applies their knowledge and practical experience in execution of bioanalytical projects on collaborative testing of reference standards, documentary standards, characterization of biological products, and proof-of-concept studies towards development of new standards for Biologics product class. Additionally, the incumbent will also actively engage and contribute in international and national reference standard development programs, USP education courses as assigned.
Roles and Responsibilities
• Aligns with USP’s mission, goals and objectives; complies with USP’s guidelines and other requirements.
• Independently plans, executes, performs data analysis and drafts report for Compendial Reference Standards and R&D projects for product classes such as proteins, monoclonal antibodies, peptides, antibiotics and any other biological products as assigned.
• Complies with USP’s quality systems and ensures data integrity.
• Reviews and compiles project reports as per USP’s quality systems and procedures.
• Demonstrates strong skills and expertise in Bioanalytical methods in the areas of basic and advanced Chromatography and Electrophoresis, Mass Spectrometry, Spectroscopy techniques and Enzyme assays.
• Routinely applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory.
• Provides technical training to lab Scientists.
• Assists and recommend improvements to the group leader in methods and processes.
• Demonstrates hands-on experience in molecular characterization of peptides, proteins and Monoclonal Antibodies.
• Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
• Performs other duties as assigned.
Candidate Profile
• MSc./M.Tech./M.Pharm. with 7-9 years or Ph.D. with 2 years’ experience in relevant stream of biological sciences.
• Experience should include strong technical knowledge and practical experience in Bioanalytical area.
• The candidate should have expertise in method development and validations in the area of Chromatography, Spectrometry and Electrophoresis.
• The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the above-mentioned analytical techniques and should have sound knowledge of QMS systems
• M.Sc. (Biochemistry, Biotechnology)/ M.Tech (Biotechnology)/ M.Pharm /Ph.D. (Biotechnology, Biochemistry) with practical hands-on experience on advanced techniques such as Circular Dichroism, Fluorescence Spectroscopy, Capillary Electrophoresis, Mass Spectrometry, Chromatography and Enzyme Assays.
• Ability to plan, design, execute, trouble shoot, and resolve technical issues within the scope of work.
• Experience in biopharma industry is strongly preferred.
• Previous experience working in cGLP/cGMP/QMS environment with practical experience in good documentation practices. Exposure to regulatory/ISO audits would be an advantage.
• Should have strong competencies in communication and presentation skills.
• Expertise in method development and validations of bioanalytical methods is preferable.
Additional Information
Experience : 5+ years
Qualification : MSc./M.Tech./M.Pharm or Ph.D
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : IND 209
Functional Area : Bioanalytical
End Date : 30th August, 2019
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