Assistant Manager - Drug Substance Production (Biopharma)

Key ResponsibilitiesUpstream Production:Lead and supervise upstream operations including media preparation, seed train expansion, bioreactor operations, and harvest activities.Monitor batch performance, troubleshoot process issues, and drive continuous improvement initiatives.Ensure real-time and accurate documentation in BMRs, logbooks, ECC data, SAP transactions, and batch records.Coordinate with Engineering and Maintenance for equipment readiness, calibration, and preventive maintenance.Manage deviations, change controls, and non-conformances, ensuring timely closure and CAPA implementation.Support execution of validation and qualification activities for upstream equipment and systems.Communicate operational performance, bottlenecks, and resource needs to stakeholders.Provide guidance and training to production associates to strengthen technical and compliance capability.Buffer Preparation:Oversee buffer preparation operations, ensuring OTIF readiness and compliance to support downstream processing.Ensure correct preparation, storage, labeling, and transfer of buffers/media as per production and GMP requirements.Maintain documentation accuracy across BMRs, checklists, log sheets, ECC, and related records for buffer activities.Plan raw material and consumable usage and manage SAP inventory updates to support production schedules.Execute equipment qualification, validation, and commissioning activities for buffer systems.Investigate and manage deviations related to buffer activities and ensure proper documentation and closure.Coordinate with Engineering for calibration, equipment performance, and resolution of equipment issues.Prepare, review, and revise GMP documents, including SOPs, EOPs, BMRs, and log sheets.Train and develop buffer preparation personnel to meet competency and quality standards.Process Engineering (PE):Perform facility fit assessments for new product introduction and process modifications.Identify production constraints and support debottlenecking strategies to improve throughput and efficiency.Define and apply commissioning and qualification (C&Q) strategies for assigned projects and new installations.Review technical design documents to ensure alignment with GMP, CQV, and system requirements.Support continuous improvement initiatives in process capability, quality, and equipment performance.Support production deviation investigations related to equipment and process failures.Ensure adherence to EHS policies and risk reduction strategies.Standardize and improve upstream/downstream process efficiency including scale-up and engineering support.Collaborate cross-functionally to integrate technical, quality, and operational requirements into project execution.General:Ensure full compliance with GMP, EHS, and regulatory expectations at all timesAct as Data Owner for relevant equipment and digital systems ensuring lifecycle and data integrity managementSupport audit readiness, operational excellence, and continuous improvement cultureRequirements:Bachelor’s degree in Biotechnology, Chemical/Mechanical Engineering, Pharmacy, or related technical discipline4–7 years biopharmaceutical manufacturing experience in upstream, buffer preparation, or process engineeringStrong understanding of GMP, CQV, deviation management, validation, and SAP ERPLeadership capability with strong communication and problem-solving skillsExperience working cross-functionally in a regulated manufacturing environmentAbout The BenefitsAt Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.