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.