SENIOR EXECUTIVE

Department Details

Role Summary

Role: Senior Executive/ Assistant Manager. Key Responsibilities: • Scale-Up and Technology Transfer: Support the scale-up and technology transfer of cell culture processes to GMP (Good Manufacturing Practice) environments. • Troubleshooting and Problem-Solving: Identify, investigate, and resolve technical issues related to cell culture performance, yield, and quality. • Process Monitoring: Monitor ongoing cell culture processes, including cell density, viability, and product yield. Analyse data to ensure optimal performance and compliance with regulatory requirements. • Cross-Functional Collaboration: Work with process development, quality assurance, and production teams to ensure seamless process transfers and support manufacturing campaigns. • Documentation and Compliance: Maintain accurate records of experiments, process changes, and deviations. Ensure all activities are in compliance with SOPs (Standard Operating Procedures) and regulatory guidelines. • Process Optimization: Design and execute experiments to optimize cell culture processes. • Continuous Improvement: Participate in the implementation of process improvements to enhance productivity, efficiency, and product quality. Qualifications: • Education: Bachelor's, Master's, Biotechnology, Biochemical Engineering, or related field. • Experience: Minimum of 18 months - 5 years of experience in cell culture, bioprocessing, or biomanufacturing, with a focus on upstream processes (e.g., mammalian cell culture, bioreactor operation, media optimization). • Technical Skills: o Proficient in cell culture techniques (e.g., batch, fed-batch, continuous processes). o Experience with mammalian cell lines (e.g., CHO cells). o Familiarity with bioreactor systems (e.g., single-use, stirred tank). o Hands-on experience with automated bioreactor systems and process control software. o Strong data analysis skills and experience with process monitoring tools and DOE approach. o Experience in technology transfer and scale-up activities. o Familiarity with GMP and regulatory requirements in biomanufacturing. o Basic understanding about statistical tools like JMP, SIMCA is a plus. • Soft Skills: o Strong problem-solving and critical thinking abilities. o Ability to work independently and within a team. Excellent written and verbal communication skills.

Key Responsibilities

Role: Senior Executive/ Assistant Manager. Key Responsibilities: • Scale-Up and Technology Transfer: Support the scale-up and technology transfer of cell culture processes to GMP (Good Manufacturing Practice) environments. • Troubleshooting and Problem-Solving: Identify, investigate, and resolve technical issues related to cell culture performance, yield, and quality. • Process Monitoring: Monitor ongoing cell culture processes, including cell density, viability, and product yield. Analyse data to ensure optimal performance and compliance with regulatory requirements. • Cross-Functional Collaboration: Work with process development, quality assurance, and production teams to ensure seamless process transfers and support manufacturing campaigns. • Documentation and Compliance: Maintain accurate records of experiments, process changes, and deviations. Ensure all activities are in compliance with SOPs (Standard Operating Procedures) and regulatory guidelines. • Process Optimization: Design and execute experiments to optimize cell culture processes. • Continuous Improvement: Participate in the implementation of process improvements to enhance productivity, efficiency, and product quality. Qualifications: • Education: Bachelor's, Master's, Biotechnology, Biochemical Engineering, or related field. • Experience: Minimum of 18 months - 5 years of experience in cell culture, bioprocessing, or biomanufacturing, with a focus on upstream processes (e.g., mammalian cell culture, bioreactor operation, media optimization). • Technical Skills: o Proficient in cell culture techniques (e.g., batch, fed-batch, continuous processes). o Experience with mammalian cell lines (e.g., CHO cells). o Familiarity with bioreactor systems (e.g., single-use, stirred tank). o Hands-on experience with automated bioreactor systems and process control software. o Strong data analysis skills and experience with process monitoring tools and DOE approach. o Experience in technology transfer and scale-up activities. o Familiarity with GMP and regulatory requirements in biomanufacturing. o Basic understanding about statistical tools like JMP, SIMCA is a plus. • Soft Skills: o Strong problem-solving and critical thinking abilities. o Ability to work independently and within a team. Excellent written and verbal communication skills.

Educational Qualifications

Required Education Qualification: M.Sc
Required Experience: 4 - 8 years