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Posted 2 weeks ago
Senior Research Associate-R&D
Job description
Be the First to Apply 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&D Job Description JD 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. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.