Job Summary:
 

We are looking for a skilled and experienced Senior Production Scientific Officer to support the production of advanced therapeutic products, including cell and gene therapies and other innovative modalities. This role involves the scientific and technical aspects of production and contributes to process optimization, scale-up, and development, and driving efficiency and innovation.

Key Responsibilities:
 

• Process Development and Optimization:

      - Work with R&D teams to scale up production processes from pilot to full-scale manufacturing
      - Optimize production workflows to improve yield, reduce costs, and maintain product quality
      - Lead the validation of new processes, equipment, and technologies in production

• Team Leadership and Training:

      - Mentor and guide team members on scientific and technical aspects of manufacturing

• Technology Transfer:

      - Oversee the transfer of processes and technologies from R&D to manufacturing
      - Ensure effective communication and collaboration between production and process development teams

• Data Analysis and Reporting:

      - Analyze production data to identify trends, deviations, and opportunities for process improvements
      - Prepare and present technical reports to internal stakeholders and management

• Innovation and Continuous Improvement:

      - Stay updated with industry trends, technologies, and best practices to enhance production capabilities
      - Evaluate and implement new technologies to maintain competitive production standards
 

Qualification:
 

• Master's in biotechnology, biochemistry, biomedical engineering, or a related scientific field with minimum 2 years of experience in GMP manufacturing of advances therapeutics, biologics, or similar products. Those with less experience may be consider for the Production Scientific Officer role.
• Expertise in cell culture, bioprocessing, or other relevant production techniques
• Strong knowledge of GMP regulations, quality systems, and regulatory guidelines (FDA, EMA, etc.)
• Familiarity with single-use systems, bioreactors, and aspetic processing
• Excellent organizational, communication, and leadership skills
• Strong problem-solving and decision-making capabilities