Assistant Manager Cadila Pharmaceuticals

7.0 - 12.0 years

6 - 12 Lacs

dholka, ahmedabad

Work from Office

Working on unit operations related to upstream processing during DS Manufacturing. GMP Documentation related to DS manufacturing. Preparation of documents like SOPs, MMDs and QMS related documents like change control, deviation, CAPA, Risk assessment. Preparation and maintenance of virus stocks. Coordination with cross-functional team. Involvement during regulatory audit preparation.

Posted Date not available

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R&D - Downstream MJ Biopharm

4.0 - 9.0 years

4 - 7 Lacs

pune

Work from Office

Hi, We are hiring for the Executive / Sr Executive R&D - Downstream role Experience - Location - Hinjewadi phase 2 Key Responsibilities: Planning & Scheduling: Prepare monthly experimentation plans, ensuring the availability of resources such as manpower, raw materials, consumables, and equipment. Team Leadership: Lead a small team, ensuring optimal utilization of processes, equipment, and consumables. Provide training and guidance to team members Key Responsibilities: Problem-Solving & Troubleshooting: Proactively identify and resolve issues in experimentation, batch processing, and equipment operation in the PDL and Pilot Plant section. Safety & Compliance: Ensure strict adherence to cGMP, GLP, and EHS protocols, maintaining compliance in all operations. Employee Development: Conduct gap analysis and competency mapping for training needs. Focus on on-the-job training (OJT) for continuous development of staff skills. Documentation: Prepare and maintain process development, scale-up, and technical documentation. Ensure accurate and timely record-keeping in compliance with GDP. Cross-Functional Coordination: Collaborate with Engineering, QC, and other departments for effective execution of plans and implementation of new technologies, including equipment modifications and cGMP requirements. Key Requirements: Experience: 6+ years in R&D or biopharma-related downstream processes with hands-on experience in upstream/fermentation/recovery. ACTA Expertise: Proficiency in using ACTA, especially in the R&D context, for process optimization and data management. Technical Knowledge: Strong understanding of QBD-guided process development, scale-up, and technology transfer for biotherapeutics. Leadership & Team Management: Proven ability to lead, train, and mentor a small team while managing day-to-day operations. Process Optimization: Experience with process optimization and technology evaluation to enhance production efficiency and product quality. Compliance & Safety: Knowledge and adherence to cGMP, GLP, and EHS standards, with the ability to resolve non-compliance issues. Problem-Solving: Analytical skills to identify and address process gaps, deviations, and inconsistencies in a timely manner. Documentation Skills: Strong documentation skills for preparing technical reports, SOPs, and batch records. Cross-Department Collaboration: Ability to work effectively with internal teams (Engineering, QC, etc.) and external vendors/partners to integrate new technologies and ensure process success. Process Monitoring: Ensure equipment operation, training, and process standards are maintained and continuously improved.

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Assistant Manager Syngene

10.0 - 15.0 years

11 - 12 Lacs

bengaluru

Work from Office

Provide input to Downstream for improvement of products/process. Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department. Downstream batch plan preparation as per campaign schedule. Supervise commissioning and qualification activity of BMP1 DSP related equipment. Preparation of micro batch schedule and shift planning for day-to-day activities. Monitor and follow good aseptic behavior inside the BMP1 facility. Support in audit and audit closure points. Involve in shipment of samples / final product as per packing and dispatch record. Preparation of BMRs, SOPs, IOPs & EOPs, general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents. Supervise Downstream activities of buffers preparation, Harvest, purification and final filtration, Calibration of operations equipment. Monitoring and process control of specific operations of downstream. Compliance to current good manufacturing practices. Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required. Perform room owner responsibility for the assigned DSP area. Maintain facility and assigned zone all-time ready for visit and audit. Involve in Shipment of samples /final product as per packing and dispatch record. Review of executed Documents on time. Education and Experience Education Graduate or Master s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 10 - 15 years of relevant practical experience in Downstream process Production for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc.

Posted Date not available

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