United States Pharmacopeia looking for Scientist | M.Pharm, MSc

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Post : Scientist II-CHM

Job Description
Summary of the Position
This is a non-supervisory position 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
• Literature search for the USP/NF/FCC projects.
• To ensure the project's requirements by coordinating with the Group Leader.
• To involve in project execution, method development, and validation of USP/ NF/FCC projects.
• To ensure the knowledge on different drug product handling and sample preparations.
• Provided effective technical and scientific expertise regarding drug substance and drug product analytical development
• Engage in project planning, execution, method development, and validation of projects according to set standards as USP general chapters, guidelines, SOPs, and protocols.
• Ensure the project updates are provided to the supervisor regularly.
• To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.
• Responsible for preparation and review of SOPs, protocols, reports, etc.
• Responsible for the review of the records and documents.
• To 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.
• To indent the required glassware, chemicals, and columns for the USP/NF/FCC projects.
• To maintain GLP & safety procedures while working in Lab.

Candidate Profile
• Master’s Degree in Chemistry with 3-5 years of experience.
• Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.
• Exposure to GMP/GLP/QMS environment and documentation procedures and champions 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 Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures.
• Awareness of ISO/IEC 17025 is desirable.

Preferred Qualifications
• Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of 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 a fair understanding of GLP regulations and exposed to external regulatory audits

Additional Information
Experience : 3-5 years
Qualification : M.Sc / M.Pharm
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CHM
End Date : 20th May, 2021