Production Specialist

About the Role

Saudi Biotechnology Manufacturing Company (SAUDIBIO), a pioneering biopharmaceutical enterprise incorporated in the Kingdom of Saudi Arabia in 2010, is seeking a highly motivated Technology Transfer Specialist to join our dynamic team at our state-of-the-art facility in Sudair Industrial City. As a key contributor to our mission of advancing biopharmaceutical manufacturing, you will play a pivotal role in driving the seamless transfer of innovative products and technologies, ensuring compliance with global standards and accelerating our market leadership in insulin production. This position offers a unique opportunity to collaborate with cross-functional teams and external partners while contributing to the growth of Saudi Arabia’s biotechnology sector.

Key Responsibilities

The Technology Transfer Specialist will be responsible for overseeing and executing critical activities that facilitate the introduction of new products and technologies into our manufacturing environment. Your core duties will include:

• Project Coordination and Execution: Support the planning, coordination, and implementation of Technology Transfer and New Product Introduction initiatives, ensuring alignment with strategic objectives and regulatory requirements.
• Documentation and Compliance Management: Maintain comprehensive project trackers, action logs, timelines, risk assessments, and readiness status reports for assigned products. Review and evaluate Technology Transfer documentation, conduct gap assessments, and ensure timely resolution of identified gaps in collaboration with internal and external stakeholders.
• Cross-Functional Collaboration: Act as a liaison between the sending unit, Manufacturing, Quality Assurance (QA), Quality Control (QC), Validation, Engineering, Supply Chain, Regulatory Affairs, and external partners to facilitate smooth technology transfer processes.
• Process and Technology Integration: Support the transfer of manufacturing, assembly, inspection, packaging, and analytical testing processes to the receiving site, ensuring adherence to cGMP standards and company procedures.
• Regulatory and Quality Support: Assist in Change Controls, risk assessments, deviation management, Corrective and Preventive Actions (CAPAs), qualification activities, process validation, and analytical method transfer to uphold the highest standards of product quality and regulatory compliance.
• Technical Support and Training: Provide shop-floor technical support during engineering runs, qualification studies, validation exercises, and commercial batch production. Contribute to technical training initiatives, knowledge transfer sessions, and continuous improvement programs to enhance operational excellence.
• Timely and Accurate Reporting: Ensure all Technology Transfer activities are completed within approved timelines while maintaining meticulous records and documentation to support audits and regulatory inspections.

Qualifications and Experience

To excel in this role, you must possess the following qualifications and professional attributes:

• Educational Background: A Bachelor’s degree in Pharmaceutical Sciences, Pharmacy, Biochemical Engineering, Biotechnology, Biology, or a closely related scientific discipline.
• Professional Experience: A minimum of 2 to 5 years of relevant experience in the pharmaceutical, biopharmaceutical, biotechnology, medical device, or regulated manufacturing industry. Hands-on knowledge of cGMP manufacturing processes and pharmaceutical quality systems is essential.
• Technical Proficiency: Demonstrated experience in supporting shop-floor manufacturing operations, qualification protocols, validation studies, or batch execution activities. Familiarity with preparing and reviewing controlled technical documentation is required.
• Collaboration and Communication: Proven ability to work effectively within multidisciplinary teams, track technical activities to completion, and communicate complex information clearly and concisely.
• Language Skills: Professional proficiency in English, both written and spoken, is mandatory to ensure seamless collaboration with global teams and stakeholders.

Work Environment and Benefits

This position is based in Sudair Industrial City, Saudi Arabia, and follows a standard work schedule from Sunday to Thursday, 8:00 AM to 5:00 PM. As part of our commitment to fostering a culture of innovation and excellence, we offer a competitive compensation package, professional development opportunities, and the chance to contribute to groundbreaking advancements in the biopharmaceutical industry. If you are a detail-oriented professional with a passion for technology transfer and a drive to deliver high-quality results, we invite you to apply and become a vital part of our success story.