Immuneel Therapeutics Private Limited is at the forefront of India’s cell and gene therapy revolution, developing innovative, personalized immunotherapies to transform cancer treatment for patients across the country. As a dynamic startup with a global outlook and a strong commitment to Indian innovation, Immuneel combines cutting-edge science with a patient-first culture that values passion, accountability, transparency, and inclusivity.
If you’re a quality assurance professional passionate about ensuring compliance in advanced biopharmaceutical manufacturing, this role offers the chance to contribute to groundbreaking therapies while thriving in a flat, agile, and purpose-driven environment.
Roles & Responsibilities
As an Analyst – Quality Assurance (Manufacturing Quality Assurance), you will play a pivotal role in maintaining product quality and regulatory compliance during manufacturing operations. Key responsibilities include:
- Conducting In-Process Quality Assurance (IPQA) activities such as dispensing verification, area/line clearance, and material reconciliation in line with cGMP standards.
- Reviewing and approving manufacturing batch records (MBRs), batch packing records (BPRs), and supporting the release of Drug Substance (DS) and Drug Product (DP) batches for clinical and commercial use.
- Preparing, reviewing, and approving Annual Product Quality Review (APQR) reports, Process Validation, Cleaning Validation protocols/reports, and managing associated deviations.
- Developing qualification strategies for equipment, reviewing User Requirement Specifications (URS), and executing/approving IQ/OQ/PQ protocols.
- Participating in facility design reviews, cleanroom qualifications, and supporting validation activities.
- Managing GMP documentation through the Document Control system, initiating/revising SOPs, policies, and QMS documents.
- Delivering cGMP training, supporting internal audits, regulatory inspections, and driving continuous improvement in quality systems.
- Contributing to QMS activities including deviations, change controls, OOS investigations, risk assessments, and implementation of digital platforms (ELN, LMS, DMS, etc.).
Required Qualifications
- Educational Background: B.Tech, M.Tech, B.Pharm, M.Pharm, or M.Sc. in Biotechnology, Biopharmaceutical Technology, Biological Sciences, Quality Assurance, or related fields.
- Experience: 4-8 years in Quality Assurance within the biotech sector (biosimilars or other biological products preferred; cell and gene therapy experience is a strong advantage).
- Technical Expertise: Strong knowledge of IPQA, batch release, sterile manufacturing, cGMP/GLP/GDP, qualification/validation, deviations/change controls/CAPA, data integrity, ICH guidelines, and electronic QMS systems.
- Soft Skills: Adaptable, team-oriented, assertive, quality-focused, organized, persistent, quick learner, good judgment, enthusiastic, and committed to continuous learning.
Salary, Benefits & How to Apply
This full-time, onsite position offers a competitive salary in the range of ₹8-15 lakhs per annum (realistic for mid-level QA roles in Bengaluru’s biotech sector, depending on experience and skills). Immuneel provides comprehensive benefits, including a focus on work-life balance, performance-oriented culture, and opportunities for growth in a mission-driven startup.
Working conditions include rotational shifts (general: 9:00 AM–6:00 PM; post-noon: 2:00 PM–11:00 PM), with two days off per week (not necessarily weekends) and occasional travel.
To apply, send your resume to careers@immuneel.com. Be part of a historic initiative bringing accessible, breakthrough cancer treatments to India!
