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About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are: Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else. Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance. Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward. Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued. Immuneel prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. Our role-based structure allows you to be cherished by the work you do and bring value to your work rather than designations, our organization is simplified into a flat, non-hierarchical, millennial, organization where you may fully inherit the role you play in the organization and are recognized by the accountability you take and the work you deliver. Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital. If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India. Interested to be a part of the next revolution in cancer treatment? Send your resume to 1. Role Title: Specialist - MSAT (CAR T Therapies) 2. Department/Function: Manufacturing Science and Technology (MSAT) 3. Reporting Structure: Reports to: Product Operations Direct Reports: Currently Individual Contributor, will have repartees as the team grows 4. Role Summary: We are seeking an individual to collaborate with various functions to enable the production of cell therapy products using safe and compliant manufacturing processes that adhere to cGMP criteria. This Individual will play a critical role in Technology Transfers, CMC life cycle management, establishing manufacturing standards, process engineering, process validation, technical oversight of external manufacturing partners and product/process capability to enable a robust, cost-effective, compliant and scalable high-quality cell therapy products. 5. Key Responsibilities: Liaison commercial manufacturing requirements to the technological team to accelerate clinical and commercial manufacturing of the next generation CAR T processes. Lead cell therapy product life cycle management for drug products and GMP manufacturing systems in the plant. Work with process and analytical development to demonstrate comparability upon process changes. Review / author technical sections of the regulatory documents / dossier. Contribute for multidisciplinary projects to create continual improvements and efficiencies within cell therapy. Build and maintain systems that continually monitor, analyze, and optimize process performance, as well as support and own quality events such as change controls, investigations, and CAPAs. Lead and actively engage in the facility's regulatory and internal audits. Lead, direct, mentor, and establish an effective MSAT team to support clinical production in a cutting-edge multi-product cell therapy manufacturing facility. 6. Competencies Required: Technical Competencies: MSAT experience in cell culture and aseptic techniques Experience in cell therapy process development and or cGMP manufacturing Experience in product / process CMC life cycle management including pre-launch, launch and post- approval. Experience in statistical software for data analysis and design of experiments Knowledge of tech transfer procedures and process validation studies Good Documentation Practices to support regulatory documents / dossiers. Lean Manufacturing and Six Sigma principles. Soft Skills: Communication Active Listening Collaborative Persuasive Result-Oriented Decisive Analytical Problem Solver Enthusiastic Optimistic 7. Qualifications: Ph.D. degree with 2+ years of experience or Master's degree with 7+ years of experience or Bachelor's degree in Chemical Engineering, Biotechnology with 10+ years of experience in working on Cell and Gene therapy (CAR-Ts) and Biological Products. 5+ years of cGMP environment / MSAT experience in cell culture and/or downstream purification. 2-3 years of experience in cell therapy process development and or cGMP manufacturing is preferred. 8. Working Conditions: Role Type: Full Time and Onsite Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday. Travel Requirements: Might require – 10% Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099