Production Assistant Manager

Job Title Assistant Manager / Senior Executive Bioprocess(Drug Substance)

Location:

Roles & Responsibilities

• Lead and supervise daily manufacturing operations involving bioreactors, fermenters, and purification systems.
• Coordinate and monitor upstream processes including cell culture, fermentation, inoculum development, and media preparation.
• Manage downstream activities such as filtration, centrifugation, chromatography, and final bulk handling.
• Review batch production records and ensure compliance with GMP, GDP, and regulatory documentation requirements.
• Troubleshoot process deviations, investigate root causes, and implement corrective and preventive actions (CAPA).
• Drive process optimization initiatives to improve yields, reduce cost, and enhance operational efficiency.
• Coordinate with QA, QC, Engineering, Validation, and Maintenance for uninterrupted production workflow.
• Support audits (internal/external), qualification, calibration, and preventive maintenance activities.
• Train and mentor junior staff, operators, and production executives on process and documentation requirements.
• Review and update SOPs, risk assessments, and production protocols as needed.
• Ensure workplace safety standards, EHS compliance, and cleanroom discipline.
• Prepare production performance reports, MIS dashboards, shift handover presentations, and improvement proposals.

Skills & Competencies

• Strong technical expertise in upstream and downstream bioprocess operations.
• Hands-on exposure to CIP/SIP systems and equipment automation technologies.
• Knowledge of GMP, GDP, regulatory guidelines (USFDA, EU-GMP, WHO), and data integrity (ALCOA+).
• Experience in deviation handling, change control, investigations, and CAPA.
• Excellent leadership, team handling, and decision-making skills.
• Strong analytical thinking, attention to detail, and result-oriented mindset.
• Good coordination and communication skills with cross-functional stakeholders.

raviteja6095@bharatbiotech.com:

Regards,

Ravi Teja M

HR Department