The U.S. Pharmacopeial Convention (USP) Senior Scientist I, Bioanalytical in Hyderabad, India
Senior Scientist I, Bioanalytical
This is a hands-on and supervisory position in USP-India’s Biologics laboratory in which the incumbent is responsible for delivering laboratory projects by independently contributing in execution of laboratory experiments, project documentation and managing laboratory activities. Deep domain scientific knowledge and laboratory experience in analysis of Biologics is required to contribute in development of reference standards, documentary standards and new initiatives for Biologics product classes such as therapeutic proteins, monoclonal antibodies and peptides using USP’s standard setting processes.
Roles and Responsibilities
Aligns with USP’s mission, goals and objectives and complies with USP’s guidelines and other requirements.
Demonstrates strong skills and expertise in molecular characterization and Higher Order Structures (HOS) of Biomolecules using advanced technology platforms such as Mass Spectrometry and other Spectroscopy techniques (e.g. Circular Dichroism, Fluorescence Spectroscopy and FTIR). In addition, performs structural analysis using computational simulations and modeling.
Demonstrates laboratory skills and expertise in analytical Chromatography (HPLC/UPLC) and Electrophoresis/Capillary Electrophoresis.
Plans and executes Compendial and R&D projects besides contributing in the new initiatives in Biologics for product classes such as proteins, monoclonal antibodies, peptides, antibiotics and any other biological products as assigned.
Performs supervisory role including administrative responsibilities, mentors and trains team member/members as assigned.
Routinely applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory within the scope.
Prepares and reviews project reports, SOPs and other documents to ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits
Assists and recommends improvements in methods and processes.
Performs other duties as assigned.
Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
- PhD. in any stream of Biological sciences with minimum 2 years of industry/post-doctoral research experience or M.Sc/M.Tech. in Biochemistry/Biotechnology or any other relevant stream with 8-10 years of industry experience working in Analytical R&D/QC department of Biopharmaceutical industry.
Ph.D. (Biotechnology, Biochemistry, Biophysics ) / M.Sc. (Biochemistry, Biotechnology)/ M.Tech (Biotechnology)/ with practical hands-on experience on advanced techniques such as Circular Dichroism, Fluorescence Spectroscopy, Mass Spectrometry, Capillary Electrophoresis and Chromatography.
Hands on experience in performing structural analysis of Biomolecules using a gamut of advanced technology platforms and computational modeling is required.
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.
Previous experience working in biopharma cGLP/cGMP/QMS environment with practical experience in good documentation practices would be an advantage
The candidate should have strong competencies in communication and presentation skills.
Job Category Scientific