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Post : Scientist II, CDL
Job Description
This is a non‐supervisory position in ARD lab performing Isolation and Characterization of impurities, analytical support and maintaining Safety & GLP environment in the lab.
In this role, the 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
• Literature search for the USP/NF projects.
• To ensure the projects requirements by coordinating with the Group Leader.
• To involve in project execution, method development and validation of USP/NF projects.
• To coordinate with Group Leader to complete the USP/NF projects within timelines.
• To ensure the knowledge on different drug products handling and samples preparations.
• To give training to the new joiner about USP/NF projects and provide support to junior staff.
• Ensure the project updates are provided to the supervisor on regularly
• Help for the team members to resolve technical challenges and criticalities.
• Complete the projects as per the time lines.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Coordinate with Group Leader for the procurement of samples, standards, chemicals, columns, glassware, etc. as per the need and availability.
• 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.
Candidate Profile
Basic Qualifications
• Master’s Degree in Chemistry with 4-6 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 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 small molecules (drug substance, drug 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 4-6 years of experience or PhD with at least 2-4 years of experience in relevant field. 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 : 4-6 years
Qualification : Masters Degree in Chemistry or Pharmaceutical Sciences
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CDL
End Date : 25th August, 2021
