Head-Upstream Process Development (Vaccine-R&D )

Zydus Group; Ahmedabad District; On-site; INR 6,000,000 - 9,000,000; Full time

Job summary

Zydus Group in India is seeking a senior leader to head upstream vaccine process development, focusing on scalable and robust methods across cell culture, fermentation, and bioreactor technologies. You will guide lab- to pilot-scale experiments and drive successful scale-up with reproducible results.

You will manage technology transfer to manufacturing, provide production support, and prepare regulatory dossiers while coordinating with QA, QC, and project teams to ensure timely execution.

Qualifications

• PhD or MSc/MTech/BTech in Biotechnology/Life Sciences/Microbiology.
• 18–20 years of vaccine/biotech process development experience.
• Experience leading a highly skilled scientific team.

Responsibilities

• Lead upstream process development for vaccines with emphasis on scale-up and robustness.
• Plan and supervise lab-scale to pilot-scale experiments ensuring reproducibility.
• Coordinate technology transfer and provide production support.
• Prepare regulatory dossiers and support submissions.
• Collaborate with QA/QC, Manufacturing, and Projects for timely execution.
• Ensure GMP/GLP compliance and support audits and inspections.
• Review SOPs, protocols, reports, and batch documentation for accuracy.

Skills

Cell Culture

Fermentation

Bioprocess Development

Process Technology

Data Analysis

Scientific Interpretation

Education

PhD or MSc/MTech/BTech in Biotechnology/Life Sciences/Microbiology

Job description

Lead and manage development of upstream processes for vaccines; ensure scalability and robustness

Plan, supervise, and execute lab-scale and pilot-scale experiments; ensure successful scale-up and reproducibility

Technology Transfer & Manufacturing Support

• Ensure smooth transfer of processes to manufacturing; provide troubleshooting and technical support during production

Prepare and review regulatory dossiers; support submissions and presentations to regulatory agencies

Cross-Functional Coordination

• Collaborate with QA, QC, Manufacturing, and Project teams to ensure alignment and timely execution

Quality Systems & Compliance

• Ensure adherence to GMP/GLP; implement quality systems; support audits and inspections

Documentation & Approvals

Review and authorize SOPs, protocols, reports, and batch documents ensuring compliance and accuracy

Role Requirements – Education + Experience

Mandatory – P.hd. /M.Sc./MTech./B.Tech. (Biotechnology /lifesciences/Microbiology).

• 18-20 years of experience in Vaccine /biotech process development
• Strong exposure to Scientific Process development skills
• Experience in managing highly skilled scientific team.

Technical Skill

• Cell Culture & Fermentation Expertise
• Bioprocess Development & Optimization
• Mammalian, bacterial, yeast, and viral cell culture system
• Seed train development and scale-up strategie
• Bioreactor & Process Technology
• Process Characterization & Validation
• Data Analysis & Scientific Interpretation