Executive/ Senior Executive For Drug Substance Manufacturing

Experience: 05-09 Years

Designation: Executive/Sr.Executive

Qualification:M.Sc/M.Tech/B.Tech (Biotech/Biochemistry)

Role & responsibilities :

USP

• Execute upstream processing operations, ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
• Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
• Perform upstream  processing activities, including vial revival, seed propagation, Media & Feed preparation, Bioreactors operation, and clarification process.
• Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR) and other GMP documents , maintaining up-to-date, accurate records.
• Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufactuing
• Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.
• Operate, manage & perform troubleshooting of all USP equipments, including RM, single-use bioreactors, depth filtration systems, pallet tanks, autoclaves, and IPQC equipment.

DSP

• Execute Downstream processing operations, ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
• Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
• Performing Downstream processing activities, including Chromatography, Virus inactivation, TFF, Virus removal, Buffer and solution preparation.
• Performing Resolute Column packing activity using Packing station.
• Operate, manage and perform trouble shooting of DSP equipment, chromatography systems, TFF system, Buffer preparation system and other downstream processing equipment
• Review and maintenance of Logbooks on shop-floor. Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR), and other executed documents.
• Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufacturing
• Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.

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