Senior Executive - Analytical Development

5 - 9 years

0 Lacs

Posted:22 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a candidate for this position, you will be responsible for working in compliance with cGMP guidelines and SOPs. Your primary focus will be aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Key Responsibilities: - Perform instrument calibration and maintain instruments/equipment according to SOPs - Follow safety precautions outlined in laboratory procedures - Conduct method development studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Perform method validation studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Analyze routine samples and stability studies for Drug Product & In-process Materials related to Peptides - Prepare Study Protocols and Study Reports - Analyze Oligonucleotides (DNA & RNA molecules) of single strand (Sense and Antisense) and Duplexes molecules - Develop IEX and Ion Pair methods for Sense and Antisense to separate charge variants in DNA and RNA molecules - Develop SEC method to separate size variants in DNA and RNA molecules - Isolate Peptide molecules from impurities by PREP HPLC Qualifications Required: - Proficiency in working as per cGMP guidelines and SOPs - Experience in instrument calibration and maintenance - Knowledge of method development and validation studies for pharmaceutical products - Familiarity with analyzing Oligonucleotides and developing methods for DNA & RNA molecules - Expertise in chromatography techniques such as IEX, Ion Pair, SEC, and PREP HPLC (Note: Additional details about the company were not included in the provided job description),

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