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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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