Principal Scientist, Process Chemistry/CDMO/ Pune Maxis Clinical Sciences

13.0 - 20.0 years

20 - 35 Lacs

pune

Work from Office

Hiring for Principal Scientist for a leading Pharma MNC at Pune. Role & responsibilities Reporting to : Associate Director Job Summary : To develop synthesis processes of highly potent and/or cytotoxic ADC drug-linkers and transfer processes to internal/external clients and collaborate with manufacturing teams to deliver robust chemical processes that are suitable for commercial-scale manufacturing, while ensuring safety and regulatory compliance. Key Responsibilities: 1. Detailed technical evaluation of project enquiries received from the customers/ BD team. 2. Literature search, scouting the appropriate routes, and Drug-linker process optimization. 3. Execution of Bioconjugation Chemistry in lab and GMP manufacturing on Lab scale. 4. Collaborating with synthetic/analytical chemists, bioconjugation scientists, biologics development team, engineers, PM, DQA, IPMG, BD, PE/TT, manufacturing units, and regulatory teams to develop and support the commercialization of ADCs. 5. Support for kilo lab batches and during commercial campaigns to achieve the QOTIF. 6. To help grow the ADC teams capabilities, research facilities, and enhance the ADC's portfolio. 7. Thorough drug-linker process development and support regulatory submissions, often with compressed timelines. 8. When appropriate, mentor, train, and supervise junior team members in this role. 9. Help drive internal facilities growth to support highly potent and/or cytotoxic material handling. 10. Manage multiple projects and/or material deliveries simultaneously. 11. Monitor and implement safety in the laboratory. 12. Troubleshoots technical challenges during scale-up & tech transfer, monitors schedules, and manages documentation in line with GMP guidelines. Preferred candidate profile Required Qualifications and Experience: MSc organic chemistry with 13+ years of relevant industrial experience in the process development/optimization of ADCs or PhD/post-doctorate in synthetic organic chemistry with experience in ADC drug-linkers. Key Competencies: Problem solving. Conflict resolution. Decision making. Communication skills. Leadership. Negotiation. Collaboration. Cross-functional collaboration. Technical Skills: Proficient in using MS Office. Knowledge of ADCs, Knowledge of High-potent API, Knowledge of working in GMP set-up, organic/process chemistry & safety API process development, tech transfer & manufacturing, proficient analytical skills for small as well as large molecules. to apply please share Resumes with Puja.k@maxisclinical.com Regards Puja

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