The U.S. Pharmacopeial Convention (USP) Senior Scientist II - Analytical Research and Development (I&C) in Hyderabad, India

Senior Scientist II - Analytical Research and Development (I&C)

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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

Required Skills

  • 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.

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.

Job Location

Hyderabad, Andhra Pradesh, India

Position Type


Job Category Scientific