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Manager – Analytical R&D

Sun Pharmaceuticals Industries Inc.

Cranbury, New Jersey
Job Code:
Sun Pharmaceuticals Industries Inc.
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Job Details

Manager – Analytical R&D, Sun Pharmaceuticals Industries Inc., Cranbury, NJ. Manage, coordinate, prioritize and lead the activities related to method development, method validation and method transfer for testing of raw materials, drug substances and drug dosage forms. Planning and Execution of analytical method development (by QbD approach) and method validation for determination of impurities, residual solvents, assay, identification, dissolution for multi-component dosage forms of tablets, capsules, lozenges, transdermal systems, suppositories, suspensions, solutions using HPLC, UPLC, Ion Chromatography, Gas Chromatography, GC-MS, LC-MS, ICP-MS,UV-visible spectrophotometer, Infra red (FTIR) spectroscopy, Atomic absorption spectrophotometer (AAS), Flurometry, Malvern particle size analyzer and other analytical instruments. Study design and test execution of laboratory-based in vitro manipulation and extraction studies (Category 1) for abuse deterrent formulations. Coordinate and execute assigned projects and activities; develops project goals and timeline in compliance with Standard Operation Procedures (SOPs), Good Laboratory practices (GLPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines. Oversee the analysis and provide analytical support to formulation R&D for formulation development batches, competitor products, drug substances, excipients, packaging materials, Bio-relevant/multimedia dissolution testing, pre-formulations studies, excipient compatibility studies, reverse engineering (deformulation) and stability study for the new drug product development. Review and/or approve technical documents like method development report, method validation protocol & report, residual solvents evaluation report as per USP chapter <467>, method of analysis, specification, templates, worksheets, SOPs, stability summary sheets, analytical raw data and COAs as per current guidelines an as per current USP, ICH, and FDA. 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.


Bachelor degree in Chemistry, Pharmacy, Pharmaceutical Science or foreign equivalent and five years of progressive, post-baccalaureate experience in the position of Chemist or Senior Chemist. Experience must include three years in pharmaceutical industry performing reviewing all associated paperwork to ensure cGMP (current Good Manufacturing Practices) and that products meet specifications and FDA guidelines and review chemical sampling, inspection, granulation, milling, blending, encapsulation and coatings.

Please apply to: Human Resources, Sun Pharmaceutical Industries Inc., 270 Prospect Plains Road, Cranbury, NJ 08512. Please reference Job-ID: 273591.

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