AAV Adeno Associated Virus Jobs in Bengaluru

Key Responsibilities: Cell Therapy Product Development: Lead the development of new cell therapy products, overseeing the validation process to ensure successful transition to the next stage of product development. Cell Culture Techniques: Apply extensive experience in different types of cell culture techniques, ensuring the optimal growth and maintenance of cells required for therapy products. Large-Scale Bioreactor Operations: Oversee the operation of large-scale bioreactors for biologicals, catering to both commercial and clinical requirements. Ensure that all aseptic operations are performed to the highest standards. Gene Transfer Methods: Utilize and manage both viral and non-viral methods of gene transfer, incorporating these techniques into cell therapy protocols. Equipment and Facility Maintenance: Maintain equipment and facilities in compliance with industry standards, ensuring the implementation of effective calibration, preventive maintenance, and validation programs. Documentation & Reporting: Prepare and review cGMP-compliant documentation, including SOPs, batch records, checklists, protocols, and reports. Ensure that all documentation is accurate and up to date for regulatory purposes. Team Leadership & Collaboration: Lead a team, providing critical technical and scientific recommendations, troubleshooting, and fostering innovation. Manage the day-to-day activities of team members while encouraging excellence in all aspects of work. Cross-Functional Collaboration: Work closely with cross-functional teams to advance the company s cell therapy pipeline, collaborating effectively in a matrixed team environment. Production Planning: Organize workflow by assigning responsibilities and preparing work schedules to ensure that production targets are met efficiently. Adherence to Project Timelines: Exhibit strict adherence to project timelines, ensuring that quality, safety, integrity, and accuracy are maintained throughout the development and production process. Sterile Practices & Compliance: Understand and enforce systems and processes related to sterile practices, safety protocols, work ethics, and environmental health standards. Key Skills: Cell Therapy Development: In-depth experience in the development of cell therapy products, with the ability to manage the entire development lifecycle from early-stage research through to product validation. Cell Culture Expertise: Expertise in cell culture techniques, both in small and large-scale systems, ensuring cell integrity and performance for clinical and commercial applications. Bioreactor & Aseptic Operations: Proficiency in large-scale bioreactor operations and aseptic techniques, ensuring contamination-free environments for cell and tissue production. Gene Transfer Methods: Hands-on experience in viral and non-viral gene transfer methods, including plasmid DNA transfections and viral vector-based techniques, critical for gene therapy applications. cGMP Documentation: Familiarity with preparing and reviewing cGMP documents, such as SOPs, protocols, and batch records, ensuring compliance with regulatory requirements. Team Management: Leadership skills to manage, guide, and motivate a team, ensuring high levels of collaboration, productivity, and excellence. Problem-Solving & Troubleshooting: Excellent troubleshooting skills, with the ability to innovate and provide technical solutions in the face of operational challenges. Cross-Functional Collaboration: Ability to collaborate across various teams and functions, working towards shared goals and the successful advancement of the cell therapy pipeline. Project & Time Management: Ability to manage multiple projects simultaneously, ensuring that work is completed on time while maintaining high quality and safety standards. Competencies: Leadership & Team Development: Strong leadership skills, with the ability to direct and motivate a team, fostering an environment of growth, innovation, and high performance. Communication Skills: Excellent verbal, written, and presentation skills, with experience in writing grants and research articles. Ability to effectively communicate with internal teams, external collaborators, and stakeholders. Attention to Detail: High attention to detail, ensuring accuracy and precision in all aspects of product development, documentation, and operational procedures. Problem-Solving & Innovation: Ability to troubleshoot and solve complex scientific problems, utilizing innovative approaches to overcome technical and operational challenges. Adaptability & Efficiency: Demonstrated ability to adapt to changing priorities and work in fast-paced, high-pressure environments while maintaining efficiency and meeting production targets. Quality & Safety Focus: Strong focus on maintaining high standards of safety, quality, and compliance throughout all phases of cell therapy development and production. Qualification : M.Sc. / MTech in Life Sciences with 12-18 years of experience in GMP Productioninvolving intense Cell Culture

Key Responsibilities: Primary Cells & Cell Lines: Work with primary cells and cell lines in the context of immunology and immuno-oncology, with experience in developing and validating cell and gene therapy products. Cell-Based Assay Development: Lead the development and execution of cell-based assays, including immunological and immuno-oncological assays, for assessing the efficacy and safety of therapeutic products. Molecular Biology Techniques: Apply molecular biology techniques such as PCR, qPCR, cloning, and real-time PCR to analyze cellular responses and validate product candidates. Flow Cytometry & Sorting: Utilize flow cytometry and sorting techniques for detailed cell characterization, analysis of immune responses, and product quality control. Cross-Functional Collaboration: Collaborate closely with internal teams across manufacturing, quality assurance, clinical development, and supply chain management to advance the cell therapy pipeline. External Collaboration: Engage and coordinate with external collaborators, including contract research organizations (CROs) and vendors, to ensure smooth development and execution of the cell therapy product lifecycle. Project Management: Exhibit strict adherence to project timelines, ensuring that all work is completed on time while maintaining the highest standards of accuracy, integrity, safety, and quality. SOP & Documentation: Prepare and review Standard Operating Procedures (SOPs), protocols, regulatory documents, and reports in alignment with program requirements and compliance guidelines. Sterile Practices & Compliance: Adhere to systems and processes related to sterile practices, safety protocols, work ethics, and environmental health and safety standards. Key Skills: Cell-Based Assays: Expertise in the development and execution of cell-based assays, especially in immunology and immuno-oncology contexts. Ability to assess immune responses and therapeutic efficacy. Immuno-Oncology Knowledge: Deep understanding of immuno-oncology, including cellular and molecular mechanisms of cancer immunity, and how to translate this knowledge into therapeutic strategies. Molecular Biology Techniques: Proficiency in molecular techniques like PCR, qPCR, cloning, and real-time PCR for gene expression analysis, assay development, and validation. Flow Cytometry & Sorting: Expertise in flow cytometry, sorting, and analysis of cellular subsets, with an understanding of how these techniques can be applied to immuno-oncology. Stable Cell Line Generation: Experience in generating and maintaining stable cell lines for therapeutic and assay development purposes. Cross-Functional Team Collaboration: Proven ability to effectively work and communicate within a highly matrixed team environment, working across various functional areas to achieve product development goals. Vendor Management: Strong experience in managing external vendors, including CROs and service providers, ensuring timely and quality execution of outsourced activities. Competencies: Immunological and Immuno-Oncological Expertise: In-depth knowledge of immunology and immuno-oncology, with practical application to cell therapy development. Molecular Biology: Expertise in PCR, qPCR, cloning, and other molecular techniques used for gene analysis and validation of cell therapy products. Effective Communication: Strong verbal and written communication skills, with the ability to present complex data clearly and interact effectively with both internal and external stakeholders. Collaboration & Teamwork: Excellent interpersonal skills, able to collaborate effectively within teams and across functions to drive the progress of the cell therapy pipeline. Project Management: Ability to adhere to timelines and manage multiple projects effectively, ensuring that deadlines are met while maintaining quality and compliance. Vendor & Stakeholder Management: Competency in managing relationships with external partners, ensuring that project goals and deliverables are met to the required standard. Qualification : M.Sc. / MTech in Biotechnology with 3-7 years of experience in GMP Production