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Post : Team Lead, Senior Scientist II, Analytical Research & Development
Brief Job Overview
This is a supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Senior scientist-II will work on isolation/ purification of known and unknown impurities/compounds by preparative HPLC and characterization of molecules using various analytical technique and Analytical Method Development for in process samples received from synthetic Lab. The successful candidate will also reviews/monitors isolation/ purification of known and unknown impurities, routine analytical tests, maintains safety & GLP environment in the lab including evaluation of reference standards, development/validation (as per requirement) of official methods, stability studies, and research projects in analytical department.
Job Description
The Sr. Scientist II has the following responsibilities :
• [50%] Review the isolation/ purification of known and unknown impurities/compounds by preparative HPLC and Characterization of molecules using various analytical techniques and review sample analysis reports as per monograph / in-house procedures including reaction monitoring. Prepare development reports for Synthetic Support projects (USP-NF and PAI). Involve in project acceptance & approvals. Ensure the project's requirement by coordinating with the purchase department. Coordinate with lab scientists to complete ARD projects within timelines. Prepare/review lab reports and documents.
• [20%] Ensure that the calibrations of the equipment’s are performed as per the schedule.Prepare, Execute and complete IQ/OQ/PQ of new instruments. Indent the required glass wear chemicals, and columns for the ARD projects. Maintain GLP & implement safety procedures.while working in Lab. Perform additional Projects/activities as per the requirement. Work inopen access instruments to support a team of synthetic scientist and deliver result in a timely manner. Support the synthetic R&D projects.
• [20%] Assist in the development and implementation of safety projects impacting all USP Laboratory personnel. Participates in USP cross-functional teams as appropriate. Develop Standard Operating Procedures and policies in ARD Lab. Coordinate with Quality Assurance staff to ensure the implementation of corrective actions. Responsible for internal, method, ISO-9001 & ISO-17025 audits
• [10%] Promote Diversity, Equity, Inclusion, and Belonging principles at USP India.
Candidate Profile
• MSc. in Analytical Chemistry / Organic Chemistry / M.Pharm, having 13-15 years' experience in Analytical Research and Development or Ph.D. with 10-13 years of experience in Analytical Research and Development
• Must have hands on experience in working with chemical methods and handling instruments like Prep HPLC and HPLC. Expertise in HPLC & Prep HPLC method development and basic undersatnding in data interpretation of various analytical technique such as LCMS, GCMS, FTIR, UV-Visible, NMR etc is required.
• Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Must be able to communicate effectively with both internal and external customers. Preferably familiar with electronic notebook documentation of experimental procedures.
• Must possess a strong work ethic and a solid record of problem solving and technical results.
• Excellent technical writing and verbal communication skills are required.
• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Proven self-effectiveness skills are a must. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirement
• Knowledge of handling , XRD, TGA, DSC, IC and ICP-MS will be an added advantage.
• General chapter information, ELN, Empower and NuGenesis will be an added advantage.
• Skilled in evaluation and interpretation of data; Ability to multi-task.
• Skilled in anticipating, troubleshooting, and solving technical problems.
• Takes personal responsibility to ensure work is delivered on time and is of the highest quality.
Additional Information
Experience : 5+ years
Qualification : Ph.D, M.Pharm, MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical Research & Development
End Date : 25th November 2024
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