BriefCase
BriefCase

Scientist / Sr. Scientist Cell & Gene Therapy Manufacturing Job in Aurigene Oncology Limited

Scientist / Sr. Scientist Cell & Gene Therapy Manufacturing

Aurigene Oncology Limited 4+ weeks ago
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Job Summary 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
Experience Required :

12 to 18 Years

Vacancy :

2 - 4 Hires

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