Immuneel Therapeutics
Website:
immuneel.com
Job details:
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’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:
Assistant Manager / Lead - Quality Control (Cell Biology)
2. Department/Function:
Quality Control
3. Reporting Structure:
- Reports to: Director - Quality
- Direct Reports: Yes
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 Assistant Manager/ Lead-cell biology focusses on qualification, validation and batch release of cell-based 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 cell biology Assistant Manager/ Lead will be responsible for data driven support in regulatory approval of the product and providing response to regulatory authorities.
5. Key Responsibilities:
- Leading and mentoring the QC-Cell biology team assigned.
- Collaborate with cross-functional teams in the operating network to support requirement towards analytical assays for ensuring product quality.
- Execution of cell-based QC assays to assure cGMP quality standards of in-process and final product as per batch or project plan.
- Qualification and validation of instruments/platforms as per regulatory requirements.
- Qualification/validation of multiparametric flow cytometry, ELISA or other cell-based assays (potency/cytotoxicity) to ensure timely delivery of QC data/reports according to regulatory standards.
- Detailed assessment of cGMP process including, but not limited to product stability, trending, comparability, qualification/validation.
- Draft documents, protocol and report preparation, execution of work plan, data compilation, analysis and interpretation of data and presentation of the data as required.
- Undergo training in new techniques as part of technology transfer.
- Maintaining operation of department (physical inventories, logs, documentation, filing, etc.) and implementation of quality improvement initiatives for QC laboratory operations.
- Adherence to standard operating procedures and good documentation practices to ensure data integrity and traceability.
- Responsible for laboratory upkeep and organization.
6. Primary Objectives:
- Team Oversight: Oversee and guide the QC Cell Biology team to ensure effective execution of routine activities and alignment with quality objectives.
- Routine QC Cell Biology Operations: Perform routine QC Cell Biology activities, including cell line maintenance, upkeep of instruments and laboratory areas, and execution of cell-based assays for product release and stability testing.
- QMS and Compliance Support: Participate in Quality Management System activities, including deviations, change controls, out-of-specification investigations, risk assessments, and related documentation.
7. Competencies Required:
- Proficiency in mammalian cell culture techniques.
- Experience in executing and interpreting cell-based assays.
- Working knowledge of flow cytometry and related analytical platforms.
- Basic understanding of quality control principles, cGMP expectations, and laboratory documentation practices.
- Experience in Biopharma industry
- Collaborative team player with adaptability to changing priorities.
- Good listener with the ability to learn quickly and apply feedback effectively.
- Strong analytical ability with attention to detail.
- Commitment to data integrity, quality, and compliance.
- Confident, self-motivated, and accountable in day-to-day responsibilities.
- Enthusiastic, persistent, and hardworking approach to achieving team and organizational goals.
8. Qualifications:
- Educational Qualification: MSc, MTech, or PhD in Cell Biology, Immunology, Life Sciences, or a related discipline.
- Relevant Experience: 3–4 years of hands-on experience in cell biology and/or cell culture techniques, with necessary experience in Quality Control (QC) operations.
- Preferred Exposure: Experience in QC testing, cell-based assays, documentation practices, and cGMP-compliant laboratory environments will be preferred.
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. If needed
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099
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