Quality Control

About ImmuneelImmuneel 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 www.immuneel.com.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 tocareers@immuneel.com1. Role Title: Quality Control2. Department/Function: Quality3. Reporting Structure: Reports to:Quality Direct Reports– Depends4. Role Summary: 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.5. Key Responsibilities:Design and develop assays/ experiments as and when needed. 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. for lab requirements. 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. Ensure the audit readiness and upkeep of labs. Strategize multiple programs in terms of priority and deliverables, in coordination with multi-functional teams/collaborators6. Primary Objectives:Complete responsibility of QC Hiring manpower and mentoring team leads Collect, analyze, and interpret data - pertinent to both scientific and lab logistics Solve problems and troubleshoot as necessary Study and present scientific literature. Present experimental data and finding in meeting7. Competencies Required:Technical Competencies: Hands-on experience in cell biology and flow cytometry Experience in molecular and microbiology techniques will be a plus point Managing teams and conflictSoft Skills: Excellent communication skills Experience in document preparation Collaborative Empathetic Customer-oriented Quality commitment Problem solver Strategic thinker Optimistic Challenge seeker8. Qualifications:MSc in Cell Biology/Molecular Biology/Microbiology Experience in cell and gene therapy Experience for 8-10 years in Biopharmaceutical industry Should have managed at least 3-5 people in a team.9. 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:Yes and Depends Base Location:Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099