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Downstream Manufacturing (Classical Fermentation)
DGM / AGM

Open

Department: Biopharma Downstream

Experience: 10 to 15 years
Qualification: Bachelor’s or Master’s degree in: Biochemical Engineering or Chemical Engineering

Published: 08 Jun 2026

Key Responsibilities

Job Description:
DGM / AGM – Downstream Manufacturing (Classical Fermentation)

Reporting To

Head –Biotech / Head- Down-Stream Process

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Job Summary

The Employee will be responsible for leading downstream processing operations for classical fermentation-based biopharmaceutical products. The role involves overseeing separation, concentration, Column Chromatography, purification, and recovery activities while ensuring compliance with cGMP, quality standards, safety regulations, and production targets as per Pharmaceutical Industry norms. The position requires strong technical expertise in downstream bioprocessing and leadership capabilities to support commercial manufacturing operations efficiently and reliably.

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Key Responsibilities:
Downstream Manufacturing Operations

Lead and manage downstream processing activities for Fermentation and Bio-Transformation-derived biopharmaceutical products.

Oversee operations including cell separation, filtration, centrifugation, extraction, concentration, chromatography drying, purification, and final product recovery.

Ensure adherence to approved batch manufacturing records (BMR), SOPs, and production schedules.

Monitor production performance to achieve yield, quality, and productivity targets.

Coordinate manufacturing activities to ensure smooth integration with upstream fermentation and final packaging operations.

Process Optimization & Technical Support

Identify and implement process improvements to enhance recovery efficiency, product purity, and operational productivity.

Troubleshoot downstream processing deviations, equipment issues, and process inefficiencies.

Support scale-up, process transfer, and commercialization of new products.

Participate in technology transfer activities from R&D to manufacturing.

Compliance & Quality Assurance

Ensure compliance with cGMP, regulatory guidelines, biosafety standards, and data integrity requirements.

Review and approve production documentation, logbooks, and batch records.

Lead investigations related to deviations, OOS/OOT events, CAPA, and change controls.

Support regulatory inspections, customer audits, and internal quality audits.

Equipment & Validation

Oversee operation and maintenance coordination for downstream equipment such as:

Centrifuges

Chromatography systems

Filtration units

Evaporators

Spray dryers / freeze dryers

Support qualification and validation activities including IQ/OQ/PQ, cleaning validation, and process validation.

Team Leadership

Manage and mentor production supervisors, engineers, operators, and technical staff.

Ensure proper manpower planning, training, and competency development.

Promote a culture of operational excellence, teamwork, and compliance.

Safety & EHS

Ensure safe handling of biological materials, chemicals, solvents, and process intermediates.

Maintain compliance with environmental, health, and safety (EHS) requirements.

Drive implementation of safe work practices and risk mitigation initiatives.

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Required Qualifications:
Bachelor’s or Master’s degree in:
Biochemical Engineering

Chemical Engineering

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Experience:
10–15+ years of experience in downstream manufacturing within biopharmaceutical, fermentation, or biotechnology focussed industries.

Strong expertise in downstream processing and purification technologies.

Experience in GMP-regulated manufacturing facilities.

Proven experience in handling commercial-scale operations and technical teams.

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Technical Skills:
Strong understanding of downstream bioprocessing principles and unit operations.

Experience with purification technologies such as filtration, chromatography, precipitation, and drying systems.

Familiarity with process automation systems, CIP/SIP operations, and manufacturing control systems.

Knowledge of cGMP, FDA, EMA, WHO, and other regulatory standards.

Proficiency in batch documentation, validation protocols, and deviation investigations.

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Behavioral Competencies:
Strong leadership and people management skills

Analytical and problem-solving capabilities

Effective communication and cross-functional collaboration

Attention to detail and quality focus

Ability to manage multiple priorities under tight timelines

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Preferred:
Experience in manufacturing of antibiotics, enzymes, probiotics, or biologics.

Exposure to SAP, MES, SCADA, or automation platforms.

Lean Manufacturing / Six Sigma certification preferred.

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