Job Description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Research Associate-R&DJD Summary -

Responsible for qualification, maintenance, and lifecycle management of reference standards using advanced analytical techniques such as NMR, LC-MS, and preparative HPLC. The role involves impurity identification, characterization, quantification, and isolation, along with providing analytical support to manufacturing sites. It also includes preparation and review of qualification reports and COAs, supporting regulatory submissions, and addressing audit and regulatory queries related to reference standards.

JD -

• Qualification of reference standards using spectroscopic techniques and Nuclear Magnetic Resonance (NMR) analysis.
• Conduct retesting, monitoring, and maintenance of reference standards in accordance with defined procedures.
• Provide analytical support to manufacturing plant locations for reference standard requirements.
• Prepare and review reference standard qualification reports and Certificates of Analysis (CoA).
• Identify and characterize unknown impurities using LC-MS techniques.
• Perform identification and quantification of impurities through LC-MS analysis.
• Isolate and purify impurities using preparative HPLC techniques.
• Support regulatory submissions by preparing documentation related to reference standards.
• Respond to regulatory queries and address audit observations concerning reference standards.