The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
POSTS:
- Scientist – II, ARD {below}
Post: Scientist – II, ARD
Job Description:
Function of the Position:
This is a non-supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Scientist II works on projects including Analytical Method Development for in process samples for synthetic chemistry support. The Scientist II performs a variety of non-routine and routine analytical tests, including development of methods, evaluation of packaging materials, stability and dissolution studies, in analytical chemistry.
Job Duties:
• Execute analysis for in-process samples including reaction monitoring.
• Involve in project acceptance & approvals.
• Execute projects per the approved test protocols.
• Prepare development reports for ARD projects as per the need
• Prepare and review of SOPs, protocols, reports, etc.
• Ensure the projects requirements by coordinating with the Purchasing department.
• Coordinate with Senior Scientist to complete ARD projects within timelines.
• Review the records and documents.
• Ensure that the calibrations of the equipments are performed as per the schedule.
• Prepare, execute and complete IQ/OQ/PQ of new instruments.
• Indent the required glass ware, chemicals and columns for the ARD projects.
• Maintain GLP & implement safety procedures while working in Lab.
• Perform other Projects whenever free from ARD / ACRL activities.
• Perform other duties as assigned.
Minimum Requirements:
Master’s degree in Chemistry with a minimum of 3 - 5 years of experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures would be an added advantage. Ability to perform analytical method developments required.
Candidate Profile:
Knowledge, Skills, Abilities:
Experience in working with wet chemical analysis, handling spectroscopic (UV-Visible, FTIR, and FT-Raman) and chromatographic equipment (GC, HPLC and UPLC) is required. Experience in working with mass spectrometric instruments like GC-MS, LC-MS and ICP-MS with a strong theoretical background in terms of spectral interpretation is desired. The incumbent must be able to communicate effectively with both internal and external customers and have a working knowledge of computer applications, such as MS Word and MS Excel.
Additional Information:
Experience: 3-5 years
Location: Hyderabad-India
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 9th NOV, 2012
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Post: Sr. Scientist I - Cell Biology
Job Description:
Function of the Position:
This is a hands-on as well as supervisory position in USP-India’s Biologics and Biotechnology Laboratory. In this role, the scientist delivers sustained contributions that result in innovative product and process technologies for USP. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical knowledge. A senior Scientist has mastered many common techniques with the laboratory and is able to contribute their own observations and input complex to difficult projects. The Scientist may execute 60% -90% of their work at the bench level depending on the size of the group.
Roles and Responsibilities:
• Assists Director in planning, implementing and evaluating laboratory procedures/systems on assigned projects.
• Demonstrates strong skill and expertise in laboratory methods in the areas of bioassays and immuno assays.
• Organizes and plans work as per timeline and project priority
• Supervises subordinates to train, review as well as guide.
• Conducts test procedures independently with minimal errors and in a timely manner.
• Reviews, and evaluates scientific literature in the relevant technical area.
• Prepares project plan, reports and reviews reports as per requirement.
• Assists in evaluation, choice and purchase of lab equipments.
• Carries out lab management activities with the help of subordinates
• Troubleshoots instrumentation within area of expertise.
• Recommends improvements to methods and processes.
• Seeks out innovative ways to apply knowledge or skills to improve protocols and results.
• Actively engages overall project, and ensures own work is aligned with overarching goals.
• Performs peer review of data.
• Executes all testing and analysis and records experimental data, ensuring clear and accurate transcription of results and calculations.
• Routinely applies personal experience, academic training, and technical insights to solve complex problems in the laboratory.
• Attends scientific seminars as appropriate.
• Demonstrates a strong desire to continue learning and grow personal capability.
• Pursues, recommends and implements new approaches or processes to improve laboratory operations.
• Performs additional duties as assigned.
Candidate Profile:
Minimum Requirements:
Ph.D/Master’s degree with not less than 6 years of relevant laboratory experience. Laboratory experience must include cell culture techniques, bioassay methods, techniques for cell staining and counting, ELISA, Flow cytometry. Must have good experience in the qualification and validation of bioassays. The candidate should have experience in managing of the functioning and maintenance of cell culture lab. The candidate should have strong knowledge and experience in handling all cell culture-related instruments (Plate reader, cell counter, incubators, centrifuges, microscope, pipettes etc. Basic knowledge in protein estimation is expected.
Knowledge, Skills & Abilities:
Experience in an IAO/cGMP environment is desirable. Understanding and knowledge of general biochemistry and molecular biology techniques is desirable. The candidate must take personal responsibility to ensure work is delivered on time and is the highest possible quality. Ability to anticipate, troubleshoots, and solves technical problems. Strong communication and presentation skills, both verbal and written. Experience working in biotechnology industry strongly preferred.
Additional Information:
Experience: 6 years
Location: Hyderabad-India
Education: M.Sc, Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 9th NOV, 2012
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Post: Scientist II – Vaccines
Job Description:
Function of the Position:
This is a hands-on, non-supervisory position in USP-India’s Vaccine Group in Biologics and Biotechnology Department. In this role, the Scientist delivers sustained contributions that result in innovative product and process technologies for USP. The Scientist will contribute to the scientific experience and work ethic of the laboratory through a broad range of technical knowledge. A Scientist has mastered some of the common techniques in the laboratory, and is able to contribute their own observations and input to projects. The Scientist at this level may execute 80% - 100% of their work at the bench level.
Roles and Responsibilities:
• Assists the group leader in implementing and evaluating laboratory procedures and systems in vaccine group.
• Demonstrates strong skill in laboratory methods in the areas of Biochemical analysis of vaccines.
• Can conduct lab test procedures with minimal supervision and errors and can interpret results correctly.
• Reviews, and evaluates scientific literature in the relevant technical area.
• Drafts project testing plans and reports for review.
• Assists in purchase of laboratory equipment and lab management.
• Troubleshoots instrumentation within the area of expertise.
• Recommends improvements to methods and processes.
• Actively engages overall project and ensures own work in aligned with overarching goals and priorities.
• Executes all testing / analysis, and records experimental data, ensuring clear and accurate transcription of results and calculations.
• Routinely applies personal experience, academic training, and technical insights to solve complex problems in the laboratory.
• Attends group and project meetings.
• Demonstrates a strong desire to continue learning and grow personal capability.
• Pursues, recommends and implements new approaches or processes to improve laboratory operations.
• Performs other duties as assigned.
Candidate Profile:
Minimum Requirements:
Master’s degree in Biochemistry or Biotechnology with laboratory experience of around 4 years, in the areas of Polysaccharide and Multivalent vaccines. Laboratory experience must include Chromatography-based techniques, electrophoresis, colorimetric assays, ELISA etc. Familiarity with vaccine characterization methods is must. Should have knowledge of basic techniques and procedures in biochemistry lab, calibrating and operating common analytical instruments, qualification of instruments, basic trouble shooting etc.
Knowledge, Skills & Abilities:
Capability of interpreting results and deriving appropriate conclusion is essential. Experience in QC activity for testing especially to follow GLP processes and documentation is desirable. The candidate must take personal responsibility to ensure work is delivered on time at the highest possible quality. Ability to anticipate, trouble shoot, and solve technical problems. Strong communication and presentation skills, both verbal and written, and experience in working in the pharmaceutical and/or biotechnology industry strongly preferred.
Additional Information:
Experience: 4 years
Location: Hyderabad-India
Education: M.Sc, Biochemistry
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 9th NOV, 2012
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