Job
Description
As a highly skilled professional with a Ph.D. specializing in Immunology or Immuno-oncology and possessing 5-6 years of experience in academia and/or industry, you will be responsible for developing new cell therapy products. This includes conducting Process Development and validations to advance the product to the next stage. Your role will involve analyzing existing processes to identify areas for improvement, designing and developing new processes, and implementing them to enhance efficiency and productivity. Additionally, you will be tasked with scaling up the production process for seamless tech transfer to the GMP scientists. Your extensive experience in developing process documentation and training materials will be crucial, as you will be monitoring and tracking process performance to ensure compliance with regulatory and legal requirements. Your expertise will also be utilized in planning, implementing, and supervising process trials, as well as advising on equipment modifications for Process Improvement. A strong background in working with various immune cells and a deep understanding of both innate and adaptive immune systems are essential for this role. Preference will be given to candidates with previous experience in gene and/or cell therapy drug development teams. Proficiency in designing and delivering genes using viral or non-viral transfer techniques, as well as constructing viral vectors using advanced molecular synthesis and cloning techniques, is required. Familiarity with gene-editing tools such as CRISPR/Cas9 or TALEN is also necessary. Your expertise in molecular biology techniques like cloning, sub-cloning, real-time and quantitative PCR will be invaluable. You should be able to multitask and contribute to multiple projects under tight timelines while upholding integrity, accuracy, safety, and quality standards. Strong verbal, written, and presentation skills are essential, and previous experience in writing grants and research articles will be advantageous. The ideal candidate will have experience in team management or working in a cross-functional group and collaborating with clients. Leadership skills are a must to drive a team towards excellence, providing technical and scientific recommendations, troubleshooting effectively, and demonstrating innovative capabilities on a daily basis. Effective communication and collaboration within a highly matrixed team environment are vital to advance the company's cell therapy pipeline. Understanding sterile practices, work ethics, safety, health, and environmental regulations is crucial. You will be involved in compliance monitoring inspections, regulatory agency interactions, and the preparation and review of protocols, reports, and regulatory documents as per program requirements. Key competencies required for this role include expertise in cell therapy design and development, preparing and implementing quality compliant documentation, exceptional presentation and communication skills, effective team management, strong interpersonal skills, adept stakeholder management, and efficient vendor management.,
