Executive – Biopharmaceutical Manufacturing

@Biocon Biologics Limited posted 2 months ago
  • Bengaluru, Karnataka, India View on Map
  • Post Date : August 19, 2025
  • Salary: ₹420,000.00 - ₹1,500,000.00 / Yearly
  • View(s) 202
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Job Detail

  • Job ID 57528

Job Description

Location: Bengaluru

Department: Manufacturing / Engineering

Experience: 0 – 3 Years

Qualification: M.Sc. in Life Sciences / Biotechnology / Bioprocess Engineering

Role Summary

We are seeking a motivated Executive to support the design, scale-up, technology transfer, and operation of large-scale monoclonal antibody (mAb) manufacturing facilities. The role involves upstream and downstream operations, process troubleshooting, facility design, automation, validation, and compliance with cGMP & EHS standards.

Key Responsibilities

  • Drive new facility design (Concept, Basic, and Detailed engineering) focusing on upstream & downstream operations.
  • Support scale-up and technology transfer for 2KL SU and 6KL SS mAb manufacturing facilities.
  • Troubleshoot upstream/downstream equipment (Bioreactors, Centrifuges, Chromatography skids, Filtration systems, UFDF/TFF, Filling, Freeze-Thaw, etc.).
  • Manage CAPEX requirements for multiple drug substance facilities.
  • Introduce new technologies and systems to enhance production.
  • Provide active support in process validation and cleaning validation.
  • Drive process automation (recipes/phases) and MES support (Siemens PCS7, CCP, Unicorn, etc.).
  • Lead process investigations, troubleshooting, and CAPA implementation.
  • Conduct technology transfer/facility fitment assessments for new products.
  • Perform process simulations using SuperPro/SchedulePro and data analytics using SIMCA.
  • Manage equipment qualification (FAT, SAT, DQ, IQ, OQ, PQ documentation).
  • Prepare and review cGMP documents (SOPs, batch records, protocols, reports).
  • Ensure compliance with cGMP practices and EHS policies.

Educational Qualifications & Skills

  • M.Sc. in Biotechnology / Life Sciences / Bioprocess Engineering.
  • 0–3 years of experience in biopharmaceutical / biologics manufacturing.
  • Strong knowledge of monoclonal antibody manufacturing processes.
  • Familiarity with automation platforms, simulation tools, and analytics software.
  • Good understanding of cGMP, regulatory compliance, and EHS standards.
  • Excellent problem-solving, documentation, and cross-functional collaboration skills.
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