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 startup 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-the-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 in being a part of the next revolution in cancer treatment? Send your resume to careers@immuneel.com

1. Role Title:

Analyst – Quality Assurance (Manufacturing Quality Assurance)

2. Department/Function:

Quality Assurance

3. Reporting Structure:

Reports to: Quality Assurance
Direct Reports: Not applicable

4. Role Summary:

The Analyst – Quality Assurance (Manufacturing Quality Assurance) is responsible for providing in-process quality oversight and supporting batch release activities to ensure compliance with cGMP and regulatory requirements. This role interfaces closely with Manufacturing, Quality Control, Facilities & Operations, Environmental Health & Safety (EHS), Regulatory Affairs, and internal QA teams to support QA operational requirements. The analyst ensures adherence to approved procedures, monitors manufacturing activities, reviews and approves GMP documentation, and supports investigations, deviations, and corrective actions to maintain product quality and compliance throughout the manufacturing lifecycle.

5. Key Responsibilities:

Perform In-Process Quality Assurance (IPQA) activities including dispensing verification, area clearance, line clearance, and material reconciliation in compliance with cGMP requirements.
Review and approve manufacturing batch records (MBRs) and support release of Drug Substance (DS) and Drug Product (DP) batches for clinical and commercial use.
Review batch packing records (BPRs) and ensure timely release of clinical and commercial batches in accordance with approved specifications and regulatory commitments.
Prepare, review, and support approval of Annual Product Quality Review (APQR) reports in line with regulatory and internal quality system requirements.
Prepare, execute, review, and approve Process Validation and Cleaning Validation protocols and reports, including deviation management and closure.
Develop and implement qualification strategies for existing and new equipment in alignment with validation master plans and risk-based approaches.
Prepare, review, and maintain apex quality documents such as the Site Master File (SMF), Validation Master Plan (VMP), and Quality Manual.
Participate in design review of plant layouts, cleanroom classifications, and facility modifications; support facility qualification and validation activities.
Review User Requirement Specifications (URS) and execute, review, and approve IQ, OQ, and PQ protocols and reports for equipment, utilities, and systems.
Conduct orientation and training for personnel involved in aseptic and GMP-critical manufacturing activities, ensuring training effectiveness and compliance.
Manage and support the Document Control and Document Management System, including issuance, revision, archival, and retrieval of GMP documents.
Initiate, review, and approve Quality Management System (QMS) documents, including SOPs, policies, and procedures related to manufacturing and quality operations.
Prepare and review quality system documentation, including qualification and validation protocols, SOPs, study protocols, qualification summary reports, risk assessments, and deviation/failure investigation reports.
Deliver cGMP training to cross-functional personnel on-site and ensure compliance with training requirements and documentation standards.
Participate in internal audits, periodic system reviews, and regulatory inspections, and support implementation of continuous improvement initiatives for quality systems, processes, and workflows.

6. Primary Objectives:

In-process manufacturing compliance ofthe clinical and commercial batches
Participation in the 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 and DMS

7. Competencies Required:

Technical Competencies:

Thorough understanding of IPQA and batch release activity
Extensive knowledge in the sterile manufacturing, GMP, GLP and GDP of various regulated (FDA, EMA) and domestic markets.
Through understanding of Qualification/validation procedures
Thorough understanding of Deviation, Change Control, investigation, route cause analysis and CAPA
Knowledge on data integrity, audit trials, ICH, and other regulatory guidelines.
Exposure of work in Digital QMS environment i.e. Electronic systems – ELN (Electronic lab notebook), ICS (Instrument calibration system), EQS (Equipment Qualification system), IMS (Inventory management system), LMS (Learning Management system), QMS (Quality management system), DMS (Document management system).

Soft Skills:

Interpersonal SkillsAdaptable: Capable of adapting to others and new situations; flexible; can handle multiple tasks
Team player: Works well with a diverse or multi-disciplinary group to achieve a common goal
Assertive: Confident or insistent in stating opinions or claiming rights without infringing on others.
Quality commitment: Has a consistent attitude and respect for high-quality standards.
Organized: Arranges work in an orderly way; has an orderly state of mind
Persistent: Refuses to give up, especially when faced with opposition or difficulty; continues firmly or steadily
Quick Study: Can master a Situation or learn new things faster than contemporaries
Judgment: Able to formulate opinions, compare and decide, has good sense
Enthusiastic: Has an intense or eager interest in something; is ardent and positive in response
Committed: Pledges oneself to a course of action and is willing to sacrifice to make it happen
Continuous learner: unusual desire to learn continuously, develop oneself and keep current

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 4-8 years of previous experience in any biotech sector, including biosimilars/any other biological products. Cell and gene therapy experience 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: Occasional travel, subject to requirement.
Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore – 560099

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