Analyst - Quality Control (Microbiology)

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 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 to careers@immuneel.com 1. Role Title: Analyst - Quality Control (Microbiology) 2. Department/Function: Quality Control 3. Reporting Structure: - Reports to: Specialist - Quality Control - Direct Reports: NA 4. Role Summary: The quality control team focuses on stringent quality check of products, coming out of manufacturing units for final release and subsequent use in the patients. The Analyst-Microbiology focusses on qualification, validation and batch release of Microbiological assays for CAR T products. The candidate will also be performing stability studies and Raw material/Packing material/Consumables, in addition to batch release tests. The Microbiology analyst is responsible for Environmental monitoring in aseptic areas and QC area. 5. Key Responsibilities: 1. Environmental monitoring in clean rooms and contamination control strategy for manufacturing facility, QC labs and other clean rooms and controlled environments. 2. Perform Sterility, BET (Bacterial Endotoxin test), and Mycoplasma test for in-process samples and finished product. 3. Follow GXP, adhere to quality SOPs, and maintain logs, inventories, documentation, filing, etc. 4. Receipt of media plates and verification of COA for received media. Media handling, growth promotion test, and maintenance of records. 5. Upkeep of reconciliation records of microbiological medias. 6. Release RM, PM, and consumables as and when required. 7. To prepare EM trends for Aseptic areas and QC EM data. 8. To involve in QMS activities as and when required. 9. Operation and maintenance of lab equipment/instruments. 10. Responsible for maintaining laboratory logbooks and records according to GXP. 11. Scientifically sound/technical writing skill and having the knowledge of different regulatory guidelines. 12. To receive an issuance of samples for QC testing and to involve in sample management activities, requesting ATRs, and maintaining sample log and batch documents. 13. Able to work for extended hours /on weekends (if required). 6. Primary Objectives: 1. To perform environmental monitoring in clean rooms and controlled environments and to perform microbiological tests and report the results. 2. To perform documentation as per (GDP) Good Documentation Practices. 3. To escalate any discrepancy identified in QC labs to the reporting manager immediately. 7. Competencies Required: - Technical Competencies: 1. To have a sound knowledge of Microbiology and aseptic practices. 2. Hands-on experience in Microbiological assays is a plus - Soft Skills: 1. Team player and Adaptable 2. Good listener and Quick learner 3. Analytical ability 4. Maintain data integrity and commitment to quality 5. Confident and Self-motivated 6. Enthusiastic, Persistent, and Hard-Working 8. Qualifications: - M.Sc. Microbiology/ Life sciences (with 2-4 years of experience). 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: No - Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore – 560099