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Senior Research Officer
Department: Analytical Research-Formulations
Location: Monroe, NC
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Glenmark is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity), with multiple molecules in various stages of clinical development & pre- clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Lifesciences Limited markets APIs to regulated and semi-regulated countries.
POSITION SUMMARY:
The role involves support to various activities that are involved in Analytical Validations and Development process for Injectable dosage forms. The goal of this role is to deliver services with an accuracy in results and within agreed timelines set by Group leader.
Responsibility:
Validation at R&D and site:
Ensure that all tasks assigned by the functional manager/Seniors are completed within time and with appropriate quality.
To conduct/execute Analytical method feasibility studies as per pre-defined protocol.
To conduct/execute Analytical validation studies as per pre-defined protocol using various laboratory instruments.
Expertise in troubleshooting and solving analytical problems related to test procedures/method with respect to HPLC and GC.
Validation Protocol and Report preparation:
Calibration and qualification of Instruments:
Ensure that all tasks completed as per SOP and according to GLP/GMP process within stipulated time.
Assist in Preparation of calibration / qualification summary Reports as per regulatory guidance - s
Coordinate with external vendors for calibration / qualification activities.
Education:
M.Pharm - Pharmaceutics Chemistry / Ph. D / M.Sc. Analytical Chemistry
Experience:
Should have 5 to 10 years- total work experience in Analytical Development and Analytical method validation
Should be well acquainted with handling below equipment like HPLC/UPLC, GC, UV Spectrophotometer, Particle Size Analyser, AAS, Autotritator etc.
Experience in handling ANDA
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