Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</li></ul>

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Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

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Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

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