The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post : Senior Scientist II - Analytical Research and Development (I&C)
Job Description
This is a non-supervisory position in Analytical R&D lab performing Isolation and Characterization of impurities, analytical support, NMR support, and maintaining Safety & GLP environment in the lab. In this role, the Sr. Scientist works on isolation/ purification of known and unknown impurities/compounds by preparative HPLC including Characterization of molecules for synthetic chemistry and reference standard development.
Roles and Responsibilities
• Coordinate with the supervisor to maintain the Lab as per GLP and safety practices.
• Execute the Isolation and Characterization projects under the supervision of the supervisor.
• Ensure the projects requirements by Coordinating with the supervisor.
• Execute and ensure routine NMR and Mass analysis to provide support to multiple users.
• Expertise in characterization of the compounds by spectral techniques like NMR, LCMS and IR spectroscopic techniques.
• Knowledge in analyzing XRD, DSC, TGA and other physical characterization analysis is an additional requirement.
• Prepare Evaluation report and complete reports for ISO 17025 collaborative projects.
• Verification of the test protocols & giving test kit approvals, if required.
• Upkeep the Preparative HPLC, Mass and NMR Spectrometer.
• Search literature for the Isolation and Characterization & NMR support projects.
• Coordinate with supervisor to meet the set timelines for projects completion.
• Responsible for preparation and review of SOPs, Protocols, reports, etc.
• Responsible for review the records and documents.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
• Ensure the lab requirements like glassware, chemicals and columns for the Isolation and Characterization & NMR lab.
• Ensure to follow USP Policies and Procedures.
• Prepare for ISO-9001 & ISO-17025 audits and related activities.
• To involve in project execution, method development and validation of USP/NF/DSC/FCC/OTC projects as and when required.
• Responsible for internal, ISO-9001 & ISO-17025 audits
Candidate Profile
• M.Sc. in Analytical Chemistry / Organic Chemistry, from a well-recognized University in India or abroad and required not less than about 12-14 years actual hands-on experience for purification and characterization of unknown and known compounds by preparative HPLC and other analytical instruments. Ph.D with 10 years Industry experience can also be considered.
• Extensive HPLC, Prep.HPLC, NMR and LCMS knowledge both in running the equipment and interpretation of results and characterization of the compound by spectral techniques (NMR, MASS and IR).
• Ability to perform various analysis like XRD, DSC and TGA etc.. techniques for characterization of the compounds if required.
• Exposure to GMP/GLP environment and documentation procedures are added advantage.
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Required Experience
• Proven track record of consistently delivering projects on time and with high quality.
• Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, BP, EP, etc.).
• Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).
• Expertise with Waters & Agilent Perp.HPLCs, NMR and LCMS software & hardware’s including extraction procedures and must be familiar with electronic notebook documentation of experimental procedures.
• Must be able to communicate effectively with both internal and external customers.
• Must possess a strong work ethic and a solid record of problem solving and technical results.
• Knowledge of various extraction methods to purify the compounds is an advantage.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• 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 desirable.
Additional Information
Experience: 10-14 years
Tracking Code: 1108-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Analytical Research and Development
End Date: 21st June, 2018
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