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Senior Scientist I, Compendial development Laboratory



Scientific

Hyderabad, AP
 • 
ID: IND 202
 • 
Full-Time/Regular

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.

This is a non-supervisory position in in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP/NF/FCC method development and method validation projects and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.

Roles and Responsibilities

  • Coordinate with supervisor to ensure GLP and safety compliance in the lab.
  • Search literature for the USP/NF/OTC/DSC/FCC/Excipient projects.
  • Ensure availability of projects requirements in coordination with the Group Leader.
  • Execute project involving method development and validation of USP/NF/DSC/FCC/OTC projects.
  • Coordinate with Group Leader to complete the USP/NF/DSC/FCC/OTC projects within timelines.
  • Assist Group Leader as deputy for preparations of project reports and compilation of data.
  • Provide training to the new joiner about USP/NF/DSC/FCC/OTC projects and provide support to junior staff.
  • Review project plans, reports, Laboratory notebook/ Electronic laboratory notebook and compile related project data.
  • Monitor projects steps such as inward, under process, archival, disposal, etc.
  • Mentor the team members to resolve technical challenges and criticalities.
  • Ensure that the calibrations of the equipment are performed as per the schedule.
  • Prepare and review of relevant SOPs.
  • Support and co-ordinate for completion of IQ/OQ/PQ for new instruments.
  • Provide hands-on training to the new joiners and existing scientists.
  • Plan and coordinate with Group leader for internal audits, ISO-9001, ISO17025 audits and related activities.
  • Provide support to Group leader for responding to QA observations on time.

Required Skills

  • Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 7-10 years of experience. Exceptional breadth of pharmaceutical industry experience. Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm. Technical and analytical skills required including the ability to interpret technical information. Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should have good understanding of GLP regulations and exposed to external regulatory audits.

Required Experience

  • Master’s Degree in Chemistry with 7-10 years of experience, or PhD with at least 3-5 years of experience in relevant field Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols. Good analytical skills in handling method development and Validations for drug substances and drug products. Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.

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