Executive – Biopharmaceutical Manufacturing

HypTechie; Bengaluru; On-site; INR 520,000 - 800,000; Full time

Job summary

HypTechie in Bengaluru seeks an Executive to support design, scale-up, technology transfer, and operation of large-scale mAb manufacturing facilities. You will handle upstream and downstream operations, automation, validation, and cGMP/EHS compliance.

The role involves troubleshooting, CAPEX management, and implementing new technologies to enhance production, with exposure to MES systems and data analytics tools.

Qualifications

• MSc in Biotechnology/Life Sciences/Bioprocess Engineering.
• 0–3 years in biopharmaceutical/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.

Responsibilities

• Drive new facility design (Concept, Basic, Detailed) for upstream & downstream operations.
• Support scale-up and technology transfer for mAb manufacturing facilities.
• Troubleshoot bioprocess equipment (Bioreactors, Centrifuges, Chromatography).
• Manage CAPEX for multiple drug substance facilities.
• Introduce new technologies and systems to enhance production.
• Support process validation and cleaning validation activities.
• Lead MES initiatives (PCS7, CCP, Unicorn) and automation recipes.
• Conduct tech transfer assessments and process simulations with SuperPro/SchedulePro.

Skills

Biopharma manufacturing

Automation platforms

Data analytics

Regulatory compliance

Problem solving

Education

MSc in Biotechnology/Life Sciences/Bioprocess Engineering

Tools

Siemens PCS7

Unicorn

SIMCA

Qualification protocols

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.