Specialist - Quality Control

Job Description

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: Specialist - Quality Control (Molecular Biology) 2. Department/Function: Quality Control 3. Reporting Structure: Reports to: Quality Direct Reports: 2-3 4. Role Summary: The primary responsibility will be hands-on wet lab analysis and managing the molecular biology team. The candidate focusses on development, qualification, and validation of molecular biology /genomics assays to test samples and generate quality control reports. Candidate is required to carry out molecular biology workflows and qPCR/ddPCR-based assays to support various tests under safety test panel required for Quality Control and Release/ Testing of Cell Therapy products. The candidate will also coordinate the sample management activities of QC. 5. Key Responsibilities: Perform hands-on experiments, validation, quality checks and guide the team. Serve as subject matter expert for the genomics, analytical & molecular biology-based QC assay requirements relevant to product safety, function, purity, identity, and other relevant parameters. Design assays/experiments, verify, qualify, and validate assays as per requirements within the target timeline. Maintain/compile/archive records, process logs, asset logs, soft copy of QA approved data, ATRs and lab notebooks. 6. Primary Objectives: Reconciliation of samples received, used for assays, remaining samples. To coordinate between QC and QA team for issuance of ATRs for each batch, distribution of ATRs to QC team, collection of ATRs after analysis from QC team, verification of ATRs for its completeness, submission to HOD, QA personnel, and HOD for signatures (as required) and filling of batch data tracker. Preparation of Certificate of analysis from QC in coordination with QA. Supervise and manage function specific inventory, material supply and equipment upkeep along with personnel responsible for this activity. The management of QC molecular biology team with instrument & consumable suppliers/vendors, engineers etc. to complete installation, qualification, calibration, PM, AMC etc. on time. 7. Competencies Required: Technical Competencies: Expertise in molecular Biology and biotechnology Industrial experience in molecular biology Managerial experience of a team Analytical ability Should have handled Quality Management Systems and audits before Soft Skills: Good communication skills Presentation skills Collaborative Assertive Decisive (Manages) stress (Handles) Ambiguity Problem Solver Strategic Thinker 8. Qualifications: MSc or Ph.D. in Molecular Biology or Biotechnology Industrial Experience in Biopharmaceutical Sector or cell and gene therapy Experience in GMP or GLP environment or laboratories with aseptic sample handling/processing facilities 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 and 0% travel Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099 Show more Show less