The U.S. Pharmacopeial Convention (USP) Manager Bioanalytical in Hyderabad, India
Summary of the Position
This is a supervisory and hands-on position in USP-India’s Bioanalytical Laboratory in which the incumbent is responsible for contributing and managing activities carried out in bioanalytical function. The incumbent with their scientific knowledge and laboratory experience will contribute towards development of Reference Standards, Documentary Standards, USP’s programs and services and new global initiatives for Biologics product classes such as therapeutic proteins, monoclonal antibodies and peptides using USP’s standard setting processes.
Roles and Responsibilities
Responsible to ensure that lab adheres to USP’s mission, goals and objectives. and complies with USP’s guidelines and other requirements.
Contributes in development of Reference Standards, Documentary Standards, USP’s programs and services and new biologics global initiatives
Perform technical supervision and managerial duties such as project updates, performance reviews, objective setting, staff development and career counseling for the team members.
Review data, project reports, draft and review SOPs and other documents and ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits.
Coordinates cross functionally in planning, implementing and evaluating laboratory procedures/systems on assigned projects.
Performs other duties as assigned.
Strong scientific knowledge and working experience in analytical technologies such as Mass spectrometry Chromatography, Capillary Electrophoresis, Circular Dichroism, MALLS etc. in the field of biopharmaceuticals as well as working experience of GLP, ISO 9001 and 17025 is required.
Knowledge of USP documentary standards and reference standards for biologics is desirable
Excellent presentation and communication skills required.
An ability to communicate effectively with, both internal and external customers.
Excellent people manager skill with a proven track record of effectively managing a team.
Ph.D. with minimum 5 years of industry experience or M.Sc/M.Tech./M.Pharm in relevant stream of biological sciences with 10 - 12 years of industry experience working in Analytical R&D/QC department of Biopharmaceutical industry.
Experience should include strong technical, practical and managerial experience in Bioanalytical area. Technical hand-on expertise on Mass Spectrometry will be required.
The candidate should have expertise in method development and validation in Chromatography (HPLC/UPLC), Spectrometry and Capillary Electrophoresis based methods for Biologics product class. In addition, knowledge and practical experience in characterization studies for Biologics product class will be desirable.
Job Category Scientific