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.