Key Responsibilities
Upstream 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 times
- Act as Data Owner for relevant equipment and digital systems ensuring lifecycle and data integrity management
- Support audit readiness, operational excellence, and continuous improvement culture
Requirements:
- Bachelor's degree in Biotechnology, Chemical/Mechanical Engineering, Pharmacy, or related technical discipline
- 47 years biopharmaceutical manufacturing experience in upstream, buffer preparation, or process engineering
- Strong understanding of GMP, CQV, deviation management, validation, and SAP ERP
- Leadership capability with strong communication and problem-solving skills
- Experience working cross-functionally in a regulated manufacturing environment
About The Benefits
At Biocon, you'll receive a competitive salary and a robust benefits packagemedical, 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.
