Upstream Manufacturing Documentation

As the Upstream Manufacturing Documentation at Syngene, your role involves leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Your expert leadership is crucial for overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. You will also be responsible for technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs to optimize efficiency, productivity, quality, and supply assurance. Key Responsibilities: - Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs. - Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirements. - Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites. - Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes. - Liaise with regulatory affairs to ensure compliance with industry standards and guidelines. - Analyze experimental data to draw meaningful conclusions and make data-driven decisions. - Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders. - Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements. - Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA. - Develop and implement strategic plans to achieve project milestones and goals. - Mentor and develop team members to foster a high-performance culture. Qualifications Required: - Masters degree/ bachelors degree in pharmacy, masters degree in Pharmaceutical Sciences. - Minimum 5 -10 years of relevant practical experience in mAbs Upstream process and documentation. In addition, you are expected to have excellent problem-solving skills, experience with automation and data analysis tools applied for cell culture bioprocessing, familiarity with regulatory submissions and quality systems in the biopharmaceutical industry, strong interpersonal skills, excellent written and verbal communication skills, and a solid knowledge of bioprocessing principles, cell culture techniques, and scale-up methodologies. Your responsibilities also include adhering to organizational policies & procedures on EHSS, POSH, Data Integrity, and IT security, always wearing applicable PPEs, and proactively identifying near-misses & potential incidents. For more information about Syngene and our services, please visit our website at https://syngeneintl.com/.,