Analyst - Quality Assurance (Analytical Quality Assurance)

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

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 Assurance (Analytical Quality Assurance)

2. Department / Function :

Quality Assurance

3. Reporting Structure :

Reports to : Quality Assurance Direct Reports : Individual Contributor

4. Role Summary :

Analytical QA is responsible for in-process and batch QC activity. He / She will interface with the internal QA, manufacturing, quality control, facilities operations, environmental health safety, and regulatory to meet the Analytical QA requirements and compliant to cGMP requirements

5. Key Responsibilities :

Analytical Quality Assurance and development quality assurance Review of specification, STP & ATR of raw material, packaging / Consumable material, in process, DS, DP finished product and stability samples. Review of CoA for raw material, packaging / consumable material, in process, DS, DP finished product and stability samples. Review of Environmental Monitoring ATR and OOT Review and assist in Analyst Qualification and its documentation Review and assist in Method Transfer, Method Validation and its associated documentation Preparation and review of the documents as per quality management processes such as standard operating procedure, Change controls, OOS, risk assessment, failure / deviation investigation reports Participation in periodic system reviews and quality audits, and implementation of improvement projects for systems, processes, and workflow. CSV knowledge and GAP assessment. Stability studies for biologics Calibration and validation of QC equipment. Facility requirements for Molecular biology, Bioassay, Microbiology, RM / PM / CM and other QC Laboratory.

6. Primary Objectives :

Analytical compliance of the clinical and commercial batches Developmental analytical assurance Participation in QMS related activities, Deviation, change control, OOS, investigation, risk assessment To access and support in the implementation and qualification of digital platforms for QMS, LMS, TMS, LIMS, and DMS

7. Competencies Required :

Technical Competencies :

Understanding of AQA and batch release activity for Biopharmaceutical manufacturing. Knowledge of sterile manufacturing and testing, GMP, GLP and GDP of various regulated (FDA, EMA) and domestic markets. Understanding of Deviation, Change Control, investigation, route cause analysis and CAPA Knowledge of ALCOA++ principles, audit trials, ICH, and other regulatory guidelines. Exposure of work in Digital QMS. LMS (Learning Management system), QMS (Quality management system), DMS (Document management system).

Soft Skills :

Adaptable Team player Assertive Quality commitment Organized Persistent Quick Study Judgment Enthusiastic Committed Continuous learner

8. Qualifications :

Educational Qualification – B. Tech, M. Tech. B. Pharma, M. Pharm, M.Sc., in biotechnology / biopharmaceutical technology / biological sciences / quality assurance with relevant experience in quality assurance of biotech / biopharmaceutical products. Based upon education, the candidate should possess 1-2 years of previous experience in any biotech sector. Freshers with relevant academic projects are eligible.

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 : when ever required Base Location : Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099