Stage Quality Control

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. 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. 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 make timely and well-informed decisions, learning from our performance. 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. Immuneel prides itself as an organization that is keeping pace with best practices in organization design. 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. 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. Quality Control Quality Reports to: Quality Overall responsibility of Quality Control activities, operations and compliance. # Prepare strategies for QC and identify areas that need continuous improvement. # Ensure timely testing and release of Clinical trial and commercial batches from QC # Leading, planning and execution of cell-based QC assays to assure cGMP quality standards of in-process and final product. Qualify, and validate assays for QC batch release. # Perform hands-on experiments, sample preps, validation of assays, quality checks etc. # Collect, analyze, and interpret data, prepare reports and other manuscripts. # Maintain/compile records, process logs, asset logs and lab notebooks. # Supervise and manage QC specific inventory, material supply and equipment upkeep. # Engage with instrument & consumable suppliers/vendors, engineers etc. Update knowledge on regulatory guidelines for FDA, EMA, ICH, USP associated with the quality control of Biologic/cell therapies # Prepare and handle QMS and related documents required for the team. # Complete responsibility of QC # Hiring manpower and mentoring team leads # Collect, analyze, and interpret data - pertinent to both scientific and lab logistics # Study and present scientific literature. Present experimental data and finding in meeting Hands-on experience in cell biology and flow cytometry # Experience in molecular and microbiology techniques will be a plus point # Experience in document preparation # Quality commitment # MSc in Cell Biology/Molecular Biology/Microbiology # Experience in cell and gene therapy # Experience for 8-10 years in Biopharmaceutical industry # 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: Yes and Depends Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore -