Assistant Manager - Downstream Processing Laboratory (R&D)

About the Role

Execution and support of experimentation of downstream processing as per study plan and discussion. Supporting data compilation and writing of laboratory notebook. To coordinate calibration, validation, qualification of the equipment, maintenance of instrument, lab maintenance and purchase requisition in downstream process development lab.

Responsibilities

• Deep understanding of the molecules, downstream purification strategies, process development and scale-up
• Design of experiments & strong troubleshooting capabilities to address process challenges during development and scale-up
• Employing DOE and QbD principles for process optimization and PC characterization
• Development and qualification of scale-down models
• Review of all key documents like RCGM consistency report, BMR, TTD, Scale-up, FMEA reports, all scale-down model protocols & reports, PC protocol and other reports
• Data review, Data compilation, interpretation, and technical presentations to internal and external stakeholders
• SPOC for assigned projects, ensuring timely milestone achievement
• Perform detailed data analysis to draw meaningful conclusions and drive data-based decisions
• Oversight of eLN /Lab book review to ensure traceability and data integrity
• Responsible to maintain oversight of instruments and equipment’s assigned to the team
• Lead downstream team process development strategy from early development to commercial readiness
• Planning and task allocation of purification activities to junior team members
• Handling and review deviations, CAPA, change controls, and risk assessments
• Cross-functional coordination with USP, DPD, DQA, MSAT, BBM mfg. and QA team
• Drive process robustness, yield improvement, cost optimization and productivity enhancement initiatives
• Support regulatory submissions and review of CMC sections
• Provide audit support during internal, client, and regulatory inspections
• Resource planning including manpower, resin, membranes, consumables, columns, and CAPAX
• Team leadership, mentoring, and performance management of junior staff.
• Responsible for training of team members and developing the scientific knowledge and presentations
• Should be aligned with Department Head for decision making.
• Ensuring data integrity and compliance with regulatory requirements

Qualifications

• Msc / M. Tech - Biotechnology

Experience

• 6 to 10 years in downstream process development or related biopharma R&D