U.S. Pharmacopeial Convention looking for Senior Scientist

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Post : Senior Scientist I, Compendial development Laboratory

Job Description
Summary of the Position

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.

Candidate Profile
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.

Additional Information
Experience :  3-10 years
Qualification : Ph.D or M.Sc, M.Pharm
Location :
Industry Type : Pharma/ Healthcare/ Clinical research

Functional Area : Compendial development Laboratory
End Date : 20th June, 2020

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