Medulla Recruitment Services Pvt. Ltd.
Website:
biojobz.com
Job details:
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.
Experience
- 8–15+ years of experience in downstream manufacturing within biopharmaceutical, fermentation, or biotechnology focused 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.
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.
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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