Design, develop, and optimize bioprocesses for the production of biologics, vaccines, or pharmaceuticals, ensuring scalability, efficiency, and compliance with Good Manufacturing Practices (GMP).
Analyze process data to enhance yield, quality, and consistency of biopharmaceutical production while minimizing variability and waste.
Collaborate with cross-functional teams, including R&D, manufacturing, quality control, and regulatory affairs, to implement process improvements and resolve production challenges.
Develop and maintain standard operating procedures (SOPs), batch records, and process documentation to ensure compliance with FDA, EMA, and other regulatory standards.
Conduct risk assessments and implement process controls to ensure safety, product quality, and adherence to Current Good Manufacturing Practices (cGMP).
Lead or support capital projects, including the design, installation, and validation of bioprocessing equipment such as bioreactors, chromatography systems, and filtration units.
Monitor key performance indicators (KPIs) such as process yield, cycle time, and product purity, generating reports to evaluate performance and guide decision-making.
Identify and implement cost-saving initiatives through process optimization, media optimization, or resource-efficient technologies.
Provide technical expertise and training to manufacturing staff to ensure proper execution of bioprocesses and adherence to SOPs and safety protocols.
Perform root cause analysis and develop corrective and preventive actions (CAPAs) for process deviations or non-conformances.
Support the development and management of process budgets, aligning with organizational financial and production goals.
Stay current with industry advancements in bioprocessing technologies, regulatory guidelines, and best practices to drive innovation and continuous improvement.
Ensure compliance with environmental, health, safety, and regulatory requirements, participating in audits, inspections, and training as needed.
Perform additional duties as assigned to support biopharma operations and organizational objectives.
Qualifications
Assist in the evaluation, selection, and validation of new bioprocessing equipment or technologies to enhance production capabilities.
Maintain accurate records of process development, technology transfer, and validation activities to support regulatory submissions and audits.
Coordinate with vendors and suppliers to source raw materials, consumables, or equipment critical to bioprocesses.
Provide technical support to other departments, such as quality assurance or supply chain, during high-demand periods or special projects.
Contribute to technology transfer activities, ensuring seamless scale-up or scale-out of processes from development to commercial production.
Foster effective communication with cross-functional teams to align on project timelines, process goals, and regulatory requirements.
