Deepak Zende

· Managed a team of Upstream and Downstream professionals, providing leadership and guidance to ensure the team's success in meeting project objectives and goals.

· Acted as the single point of contact (SPC) for USP and DSP functional responsibilities, facilitating efficient communication and coordination within the team.

· Collaborated with cross-functional teams to align with project objectives and goals, ensuring seamless integration of USP and DSP activities.

· Led the technical operations for Biologic Drug Substance USP manufacturing processes in various Biosimilar projects, ensuring quality and efficiency throughout.

· Oversaw the successful transfer of development and manufacturing technology from internal and external sites to manufacturing scale at facility.

· Conducted thorough assessments of manufacturing facilities and equipment suitability for new projects, implementing mitigation plans as needed.

· Led the scale-up process from laboratory/pilot scale to manufacturing scale, meeting specific project requirements.

· Organized internal technical meetings with cross-functional teams like R &D, MSAT, QA and QC providing mentorship on new processes and procedures, and developing effective tech transfer plans.

• Working in upstream processing operations, providing technical expertise in routine cGMP manufacturing operations at 1 KL Fermenter.
• Strong experience of working on Root Cause analysis and Impact Assessments. Identification and implementation of robust CAPAs to minimize the process deviations. Preparation of change control documents.
• Actively participated and involved in technology transfer of recombinant Human Albumin.
• Author and /or review of documents for Manufacturing process documents and data/trend analysis to identify out-of-control trends.
• Author and reviewer for documents like Process Validation studies, Hold time studies & Cleaning Validation studies for the manufacturing process.
• Effective collaboration with cross- functional teams (Manufacturing, QC, QA, R&D, MSAT etc.) to achieve consensus on complex technical problems

• Supported senior managers with day-to-day operational requirements.
• Coordinated employee schedules to provide adequate staff coverage. Delegated tasks to appropriate staff members and monitored performance.
• Collaborated with upper management to develop and implement process improvements. Monitored performance of employee teams and actions via regular performance evaluations.
• Participated in commissioning of new facility and equipments.

• Involved in manufacturing of biosimilar products based on mammalian cell culture at 2 KL scale and Microbial cell culture
• Involved in operations and troubleshooting of equipments in manufacturing process viz Bioreactor,centrifuge,Process hold vessels and transfer vessels, Single use wave bioreactor, single use bags.
• Involved in preparation of SOP, BMR and cGMP documents as per process needs
• Achieved Employee of the year in 2017 for performance.

• Joined as Trainee officer.
• learned and handled the process of manufacturing of products like Rifamycin and Lovastatin.
• complied documents like batch records,process related documents like equipment log books
• Additionally handled the responsibility for Inoculum development and seed preparation lab.
• Involved in pilot scale batches..