The U.S. Pharmacopeial Convention (USP) Scientist II, Bioanalytical in Hyderabad, India
Scientist II, Bioanalytical
This is a hands-on, non-supervisory position in USP-India’s Bioanalytical Laboratory - Biologics. In this role, the Scientist will be responsible for hands-on execution of projects on collaborative testing of reference standards, characterization of biological products, and contributing towards various project types of USP-NF (Documentary Standards, Physical Reference Standard & Performance Standards). In addition, the Scientist will also actively engage and contribute in Verification testing program and other international and national RS development programs. The Scientist will contribute to practical experience and quality systems of the laboratory through broad range of technical knowledge and QMS. The Scientist will contribute his/her own observations and inputs to projects. The Scientist at this level will execute 100% of their work at the bench level and deliver quality output required for successful completion of projects assigned.
Roles and Responsibilities:
Aligns with USP’s mission, goals and objectives. and complies with USP’s guidelines and other requirements.
Executes testing and analysis of enzymes, peptides, proteins, Monoclonal Antibodies, Antibiotics and any other biological products
Independently plans and executes Compendial projects, Verification and R&D projects, and drafts and reviews project reports for submission.
Demonstrates strong skills and expertise in Bioanalytical methods in the areas of Chromatography, Colorimetric assays, enzyme assays and Electrophoresis.
Demonstrates compliance to USP’s systems and procedures and QMS.
Drafts project testing plans and project reports for review.
Routinely applies personal experience, academic training, and technical insights to troubleshoot and solve complex problems in the laboratory.
Assists the group leader in implementing and evaluating laboratory procedures and systems.
Reviews, and evaluates scientific literature in appropriate area of biopharmaceutical analysis
Attends group and project meetings as and when required.
Demonstrates a strong desire to continue learning and grow personal capability
Performs other duties as assigned
Experience in a cGLP/cGMP environment and qualification/validation of analytical methods is desirable.
Good understanding of basic concepts in chromatography, as well as other general analytical chemistry principles.
In addition, candidate should have practical knowledge and experience in Quality systems.
The candidate must take personal responsibility to ensure work is delivered on time and is of the highest possible quality.
Ability to anticipate, trouble shoot, and solve technical problems in their purview. Strong communication and presentation skills, both verbal and written are preferred.
Master’s Degree in Chemistry, Biochemistry, Pharmacy, Biotechnology or any other related discipline with 4-6 years of relevant experience in working with biologics product class such as enzymes, peptides, proteins, Monoclonal Antibodies and Antibiotics.
Experience should include techniques like HPLC, UPLC, GC, Electrophoresis (IEF, SDS-PAGE, Western Blot), Colorimetry, Spectrophotometry.
Additionally experience in Capillary Electrophoresis, Mass Spectrometry and Immunoassays would be advantageous.
Hyderabad, Andhra Pradesh, India
Job Category Scientific