8 Gene Therapy Jobs

Role Overview: As a visionary Product Manager at our company, you will spearhead the development of innovative products for our Cell & Gene Therapy portfolio. Your role will involve designing and advancing novel therapeutic solutions from initial concept through preclinical and early clinical stages. You will closely collaborate with R&D, clinical, and manufacturing teams to deliver life-changing treatments to patients. Key Responsibilities: - Identify opportunities for new cell and gene therapy products by analyzing scientific advancements, patient needs, and market gaps. Define product concepts and initial specifications. - Create and manage the development roadmap for new therapies, prior...

As a visionary Product Manager at our company located in Chennai, you will be spearheading the development of innovative products for our Cell & Gene Therapy portfolio. Your role will involve designing and advancing novel therapeutic solutions from initial concept through preclinical and early clinical stages, in close collaboration with R&D, clinical, and manufacturing teams. Your expertise in cell and gene therapy, ability to translate scientific potential into viable products, and commitment to delivering life-changing treatments to patients will be crucial in this role. **Key Responsibilities:** - **Product Concept Development:** Identify opportunities for new cell and gene therapy produ...

Role & responsibilities - Perform in-process and release testing of CAR-T products. - Conduct assays including flow cytometry, qPCR, ELISA, and microbiological assays. - Develop, validate, and transfer analytical methods for CAR-T product testing. - Troubleshoot analytical methods and provide technical support during investigations. - Analyze and interpret QC data, prepare statistical reports, and present results to teams. - Author, review, and approve QC protocols, procedures, and documentation. - Ensure regulatory compliance with GMP QC protocols across PoC centers. - Manage lab supplies, reagents, and inventories effectively. - Lead investigations of OOS/OOT results, generate deviation re...

Job Description The Application Specialist will be responsible for offering product expertise, application knowledge and technical support along each step of customer's process and for bringing the products' technical expertise and market knowledge to the sales team. The main missions are to ensure successful design, validation and implementation of products, by supporting sales for product design, product positioning and demonstration, and supporting customers for application development work, initial startups and training. Main Responsibilities & Tasks: Support the sales organization on existing products through product presentations, demonstrations and application studies, and on new prod...

Your role at PCI as part of the Batch File Review Team will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will collaborate closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to ad...

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 documentatio...

Develop and optimize functional assays for CAR-NK and CAR-T cells; perform in vitro characterization, QC testing, and data analysis; support assay transfer and scale-up in compliance with regulatory standards.

Role & responsibilities: Lead, manage, track, and ensure the timely completion of Quality Management System (QMS)-related documents, Standard Operating Procedures (SOPs), and other departmental paperwork. Ensure the facility operates in full compliance with GMP requirements. Ensure compliance with EHS (Environmental Health & Safety) standards. Lead all aspects of facility operations, including cleanroom maintenance, equipment qualification, and environmental monitoring. Ensure all systems (HVAC, BMS, water systems, etc.) are functioning within validated parameters. Work closely with QA, Validation, and Engineering teams to support new installations, expansions, or requalification efforts. Di...