Senior Manager -Bioassay & Molecular Biology (Biologics)

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

Lead and supervise daily Bioassay & Molecular Biology QC lab operations

• Oversee routine execution, method transfer, validation of bioassays (cellbased potency assays, binding assays etc.).
• Oversee routine execution method transfer, validation of molecular biologybased methods such as ELISA, qPCR, RTPCR, sequencing, residual DNA analysis, plasmid characterization, and host cell impurities testing.
• Monitor laboratory performance metrics, turnaround times, and resource utilization to improve efficiency
• Ensure method lifecycle management as per ICH Q2/Q14 and regulatory expectations.

Troubleshooting & Technical Problem Solving

• Optimize assay performance, reduce variability, and ensure longterm method robustness.
• Serve as the primary SME for complex analytical investigations and OOS/OOT troubleshooting.
• Conduct root cause analysis and implement robust CAPAs.
• Handling analytical method queries/IRs received form agencies

Data Review, Documentation & Quality Systems

• Ensure highquality documentation, data integrity, and ALCOA+ compliance.
• Review technical documents, SOPs, protocols, reports, and regulatory (if required) dossiers.
• Continuous improvement initiatives by identifying process gaps Drive digitalization, automation, and data management enhancements.

Ensure compliance with cGMP, ICH guidelines, and pharmacopeial requirements (USP/EP/JP/WHO).

Train, mentor, and evaluate QC analysts and technicians, ensuring competency in laboratory techniques and data integrity practices.

Oversee sample management, including receipt, storage, handling, and traceability of biological materials.

Support internal and external audits and regulatory inspections, providing technical explanations and required documentation.

Coordinate with cross-functional teams such as QA, Manufacturing, R&D, and Regulatory Affairs to resolve quality issues.

Audits: Experience of handling regulatory audits - USFDA/EMA etc,.

Behavioural Competencies

• Strong leadership and decisionmaking ability.
• Excellent communication skills for crossfunctional and regulatory interactions.
• High accountability, problemsolving mindset, and attention to detail.

Additional Points

• Qualification-Masters in Biotech/Biochemistry/Microbiology
• Hands on experience in Biosimilars.
• Experience 14 to 18 years
• Experience of Physico chemical/Chromatography method considered added advantage.