Post : Manager Bioanalytical
Job Description
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.
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.
• 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.
Candidate Profile
• D. with minimum 5 years of industry experience or M.Sc/M.Tech./M.Pharm in relevant stream of biological sciences with 8-10 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.
• 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.
• Strong scientific knowledge and working experience in analytical technologies such as Chromatography, Mass spectrometry, Capillary Electrophoresis, Circular Dichroism, Protein sequencing, 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.
• D. with minimum 5 years of industry experience or M.Sc/M.Tech./M.Pharm in relevant stream of biological sciences with 8-10 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.
• 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.
• Strong scientific knowledge and working experience in analytical technologies such as Chromatography, Mass spectrometry, Capillary Electrophoresis, Circular Dichroism, Protein sequencing, 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.
Additional Information
Experience : 8-10 years
Qualification : M.Sc/M.Tech./M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1303-679
Functional Area : Bioanalytical
End Date : 5th March, 2019
Experience : 8-10 years
Qualification : M.Sc/M.Tech./M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1303-679
Functional Area : Bioanalytical
End Date : 5th March, 2019
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