Senior Executive - Analytical Development

5 - 9 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a candidate for this position, your role will involve working in accordance with cGMP guidelines and ensuring compliance with current guidelines and SOPs. You will be responsible for aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Your duties will include performing instrument calibration and maintaining instruments/equipment as per SOPs, as well as following safety precautions outlined in laboratory procedures. Key Responsibilities: - 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 conduct stability studies for Drug Product & In-process Material Drug Substance, 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: - Bachelor's or Master's degree in a relevant field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences). - Previous experience in a similar role within the pharmaceutical industry. - Knowledge of cGMP guidelines and SOPs. - Strong attention to detail and ability to follow procedures accurately. Please note that there are no additional details about the company provided in the job description.,

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