Are you passionate about advancing healthcare through innovative biosimilars? Biocon Biologics, a global leader in biopharmaceuticals, is seeking a skilled Senior Executive – QC Biosimilars (Bioassay) to join their team in Bengaluru, Karnataka. This role offers an exciting opportunity to contribute to the development of high-quality, affordable biosimilars that transform patient lives worldwide. With a robust pipeline of 28 molecules and a commitment to excellence, Biocon Biologics is the perfect place to grow your career in quality control and biosimilars development.
Roles and Responsibilities
As a Senior Executive in Quality Control (Bioassay) at Biocon Biologics, you will play a pivotal role in ensuring the quality and integrity of biosimilars. Your key responsibilities include:
- Implementing a data integrity culture in the Quality Control Lab to maintain compliance with industry standards.
- Adhering to cGMP, cGLP, and GDP practices to ensure high-quality laboratory operations.
- Conducting stability testing and managing in-process, drug substance (DS), reserve, and stability samples.
- Preparing, qualifying, and managing cell banks for bioassays.
- Planning and reviewing testing for monoclonal antibodies, biosimilars, and finished products, ensuring timely reporting.
- Reviewing analytical reports for method validation, method transfer, and stability studies.
- Preparing and reviewing protocols, stability summaries, and compilation data.
- Performing method validation, method transfer, and study sample testing.
- Verifying laboratory compliance, including reagents, standards, and system status.
- Investigating and reporting incidents, OOS (Out of Specification), OOT (Out of Trend), and deviations.
- Supporting Operational Excellence and 5S initiatives in the Quality Control Lab.
- Calibrating analytical equipment such as weighing balances and pH meters.
- Monitoring lab and equipment cleanliness and coordinating with other departments for seamless operations.
Secondary Responsibilities
- Supporting cross-functional coordination for smooth workflow.
- Assisting with Quality Management Systems (QMS) and other QC functions as needed.
- Undertaking additional tasks assigned by the supervisor or manager.
Qualifications
To excel in this role, candidates must meet the following requirements:
- Education: MSc in a relevant field (e.g., Biotechnology, Biochemistry, or related disciplines).
- Experience: 4-6 years of experience in quality control, with mandatory bioassay experience preferred.
- Strong knowledge of cGMP, cGLP, and GDP practices.
- Expertise in stability testing, method validation, and bioassay techniques.
- Familiarity with monoclonal antibodies and biosimilars testing.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively in a fast-paced, team-oriented environment.
Benefits
Joining Biocon Biologics offers a range of benefits, including:
- Competitive salary in the range of INR 8,00,000 – 12,00,000 per annum, based on experience.
- Opportunity to work with a global leader in biosimilars, contributing to innovative healthcare solutions.
- Access to professional development programs and career growth opportunities.
- Collaborative and inclusive work culture that values innovation and excellence.
- Comprehensive health and wellness benefits.
How to Apply
Ready to make a difference in global healthcare? Apply for the Senior Executive – QC Biosimilars (Bioassay) role by visiting the Biocon Biologics careers page at https://www.bioconbiologics.com. Submit your updated resume and a cover letter highlighting your bioassay experience and passion for quality control. Applications are reviewed on a rolling basis, so apply by October 20, 2025, to ensure consideration.
FAQs
1. What is the primary focus of the Senior Executive – QC Biosimilars role?
The role focuses on ensuring data integrity, conducting bioassays, and maintaining compliance with cGMP, cGLP, and GDP standards while testing biosimilars and monoclonal antibodies.
2. Is prior bioassay experience mandatory for this position?
Yes, 4-6 years of experience with mandatory bioassay experience is preferred to meet the technical demands of this role.
