The U.S. Pharmacopeial Convention (USP) Senior Scientist I - Bioanalytical in Hyderabad, India
Roles and Responsibilities
Aligns with USP’s mission, goals and objectives and complies with USP’s guidelines and other requirements.
Demonstrates laboratory skills and hands on expertise in analytical Chromatography (HPLC/UPLC/ Ion-chromatography), Capillary Electrophoresis, SEC-MALS, Circular-dichroism and Mass-spectrometry.
Perform Intact Mass, Peptide mapping, Glycan profiling, HMW & LMW, HCP, Impurity Profiling studies & PTM analysis
Plans and executes Compendial and R&D projects besides contributing in the new initiatives viz., proof of concept studies in Biologics for product classes such as proteins, enzymes, vaccines, monoclonal antibodies, peptides, antibiotics, and any other biological products as assigned.
Evaluates and analyzes scientific reports, applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory within the scope.
Performs administrative responsibilities, mentors and trains team member/members as assigned.
Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
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 laboratory/project management methods and processes.
Performs other duties as assigned.
Sc./M.Tech./M.Pharm. in relevant stream of biological sciences with 8-12 years of industry experience working in Analytical R&D and QC department of Biopharmaceutical industry.
Experience in method development, validation and technology transfer and analytical characterization for biomolecules.
· M.Sc. (Biochemistry / Biotechnology)/ M. Tech (Biotechnology / Bioprocess Engineering) / M. Pharm with practical hands-on experience on advanced techniques such as Mass Spectrometry, Capillary Electrophoresis, SEC-MALS, Circular-dichroism, Chromatography & Biochemical or Enzymatic Assays.
Knowledge of reference standards development and collaboration related to biopharmaceutical products (mAb, Peptide, Vaccine etc). Experience with reference materials manufacturing and development is a plus.
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 technical writing, communication, and presentation skills.
Job Category Chemistry & Scientific Standards
Job Type Full-Time