HEAD OF MICROBIAL BIOSYNTHESIS PROCESS DEVELOPMENT GROUP

As an experienced manager with expertise in microbial cultivation, you will lead microbial biosynthesis process development group, transfer and develop USP technologies, strategize to improve the original processes, troubleshoot and resolve technical issues, train and review the work of the team.

• Lead the microbial USP process development related activities, including commercial and development production technologies, in order to meet goals and objectives;
• Ensure the group is supported by experienced staff to control and assure the performance of biosynthesis processes;
• Accountable for the performance and results of unit;
• Develop group plans and priorities;
• Provide recommendations for efficiency, continuously looking for innovative ways to increase efficiency;
• Identify new approaches, systems to improve quality and productivity;
• Empower team to ensure ability to manage the day-to-day activities;
• Review and analyze product quality testing results evaluating the biosynthesis process impact on product quality and its compliance to pre-determined product specification;
• Evaluate gaps for bringing new technologies, equipment and microbial producer lines to the lab;
• Write protocols, review data and write final reports, review documentation prepared by the team;
• Provide regular weekly (or more frequent if required) updates on progress to direct manager;
• Participate in TCs with different clients representing the progress related with USP development activities;
• Provide assistance to management in investigations for OOS conditions.

• Science field degree (Master’s degree or PhD in microbiology, cell biology, molecular biology or related sciences preferred);
• A minimum of 3 years of experience in microbial biosynthesis process development;
• 5 + years of experience with biologics would be an advantage;
• Thorough knowledge of microbial cell biology, biosynthesis process design, development and improvement as well as hands-on experience working with different bioreactor systems and related equipment required;
• Good knowledge of, cGMPs, GLP, FDA guidelines required;
• Excellent written and verbal communication skills;
• Good computer skills;
• Capable of working independently, handling technically difficult projects;
• Experienced in planning, scheduling, executing and completing projects to meet pre-determined deadlines.