Job
Description
As the Key & Operational Lead for upstream fermentation operations, your role will involve overseeing end-to-end upstream fermentation operations, including media preparation, seed culture development, fermentation scale-up, and harvest. You will be responsible for optimizing classical microbial fermentation processes for high cell density and metabolite production using various microorganisms such as bacteria, yeast, or fungi (e.g., E. coli, Bacillus, Saccharomyces, Streptomyces). It will be your duty to ensure the consistent achievement of production targets in terms of volume, yield, quality, and timelines. You should be prepared to troubleshoot upstream process deviations, contamination issues, or yield drops. Additionally, collaborating with R&D and Tech Transfer teams for the scale-up and commercial execution of new strains or processes will be part of your responsibilities. Evaluating and implementing process improvements, automation, and cost-saving initiatives will also fall under your purview. You will need to review and ensure accurate documentation including batch records, SOPs, deviation reports, and change controls. In terms of Compliance & Quality, you will be responsible for ensuring that operations are fully compliant with cGMP, regulatory, and EHS requirements. It will be your duty to support regulatory audits from bodies such as USFDA, EMA, WHO, etc., as well as customer inspections. You should also actively participate in investigations (OOS/OOT, deviations) and implement CAPAs related to upstream activities. For Team Leadership & Coordination, your duties will include leading, mentoring, and developing a team of production officers, operators, and shift engineers. You will need to ensure the adequate training of team members on fermentation operations and GMP. Coordinating closely with downstream, QA, maintenance, and warehouse functions to ensure smooth operations will also be a key aspect of your role. As the Key & Operational Lead for upstream fermentation operations, your role will involve overseeing end-to-end upstream fermentation operations, including media preparation, seed culture development, fermentation scale-up, and harvest. You will be responsible for optimizing classical microbial fermentation processes for high cell density and metabolite production using various microorganisms such as bacteria, yeast, or fungi (e.g., E. coli, Bacillus, Saccharomyces, Streptomyces). It will be your duty to ensure the consistent achievement of production targets in terms of volume, yield, quality, and timelines. You should be prepared to troubleshoot upstream process deviations, contamination issues, or yield drops. Additionally, collaborating with R&D and Tech Transfer teams for the scale-up and commercial execution of new strains or processes will be part of your responsibilities. Evaluating and implementing process improvements, automation, and cost-saving initiatives will also fall under your purview. You will need to review and ensure accurate documentation including batch records, SOPs, deviation reports, and change controls. In terms of Compliance & Quality, you will be responsible for ensuring that operations are fully compliant with cGMP, regulatory, and EHS requirements. It will be your duty to support regulatory audits from bodies such as USFDA, EMA, WHO, etc., as well as customer inspections. You should also actively participate in investigations (OOS/OOT, deviations) and implement CAPAs related to upstream activities. For Team Leadership & Coordination, your duties will include leading, mentoring, and developing a team of production officers, operators, and shift engineers. You will need to ensure the adequate training of team members on fermentation operations and GMP. Coordinating closely with downstream, QA, maintenance, and warehouse functions to ensure smooth operations will also be a key aspect of your role.
