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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-AD
Job Description
Experienced in designing and executing solid-state screening studies, including polymorph, salt, co-crystal, hydrate, and solvate screening of APIs using crystal engineering principles and various crystallization techniques. Skilled in characterization and interpretation of solid-state forms using XRPD, DSC, TGA, IR, polarized microscopy, hot-stage microscopy, and related analytical techniques. Expertise in analytical method development and validation (particularly XRPD), physicochemical property determination, solubility and dissolution studies, instrument qualification and maintenance, and ensuring compliance with GxP, QMS, SOPs, and data integrity requirements while supporting client-facing projects and cross-functional collaboration.
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Design and perform screenings of polymorphs, salts, and co-crystals (including hydrates and solvates) of Active Pharmaceuticals Ingredients through crystal engineering principles by utilizing different screening (crystallization) methods.
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Characterization of polymorphs, co-crystals, salts and novel polymorphs, and their data interpretation of solid-state techniques such as XRPD, DSC, TGA, IR, Polarized microscopy, Hot stage microscopy and RVC.
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Review and interpretation of analytical characterization results.
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Method developments and Method Validations of analytical methods as per ICH guidelines for various solid-state characterization techniques, especially, Powder X-Ray Diffraction Techniques for both drug product as well as drug substance.
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Calibration of the analytical instruments and preventive maintenance as per calibration/maintenance schedule in solid-state characterization team.
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Perform the qualification of new analytical equipment and CSV activities and its documentation.
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Experimental physico-chemical properties determination like pKa and Log P by titration and spectroscopic techniques.
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Perform Solubility study and Dissolution studies as per guideline.
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Ensure the completion of day-to-day routine laboratory activities in solid-state characterization team.
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Perform activities with adequate diligence to ensure GxP compliance and lab safety guidance. Ensure GxP compliance (GMP, GDP, GLP) for all processes.
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Ensure compliance with SOPs and good documentation practices.
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Comply with the QMS at site and ensure the timely completion of QMS documentation wherever applicable.
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Ensure positive and timely communication with clients and other stakeholders. Involve in client calls and ensure the timely completion of projects by tracking the milestones and planning activities.
