Cell Culture Manager

ICDS Recruitment

Offaly

Cell Culture Manager - County Offaly. Summary of Role: This is a lead role within the Process Development and Manufacturing group responsible for the development, optimisation, scale-up, characterisation, technology transfer and validation of cell culture / upstream processes into this cGMP facility. The successful candidate will have demonstrated a broad knowledge base in routine mammalian cell culture, sterile techniques, establishment of cell banks, and expansion of cell lines. In addition, the candidate will be responsible for authoring technical reports, protocols, technology transfer documents and CMC sections for regulatory filings. The candidate will be interfacing with team members in the maintenance, operation, and harvesting of bioreactors in a small-scale development facility and manage the cell culture team of process scientists. The candidate will be expected to interact on a routine basis with colleagues in downstream process development and analytical methods development and clinical groups. The candidate will be responsible for evaluating and implementing new technologies in the cell culture area. Key Responsibilities: • Build, lead and develop a team with expertise in biopharmaceutical process development, specifically in the area of upstream cell culture processes using disposable technologies. • Develop, optimise, scale-­‐up and validate all steps in the upstream process. • Work with external service providers to ensure delivery of projects related to the upstream process. • Manage technical transfer of processes into the GMP production facility. • Establish Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture. • Work closely with analytical development activities to support process development and process characterisation studies. • Provide expert input into process validation programme, including cell bank production and characterisation, cleaning validation, leachable studies. • Manage production, supply and qualification of cell culture media and components. • Provide support for other processing activities including purification and buffer preparation. • Support writing of relevant sections of CTD to support regulatory submissions. • Participate in Quality and Safety regulatory audits. • Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices. Qualifications and Experience sought: • B.S/M.S. in Chemical/Biochemical Engineering or related discipline, with at least 5 – 7 years' experience. • Candidates must have hands-on experience in cell culture development processes for the manufacture of monoclonal antibodies or recombinant proteins/vaccines. • Basic knowledge and experience in scaling-up cell culture processes from Shaker flasks to stirred tank bioreactors is required. Preferred Qualifications: • Ph.D. in Chemical/Biochemical Engineering or related discipline with 2 – 5 years' experience or B.S/M.S. in Chemical /Biochemical Engineering or related discipline with 7 – 10 years' experience. • At least 2 – 5 years' management experience in bioprocess, development, manufacturing environment. • A demonstrated record of scientific achievement and a broad and integrated knowledge of the cell culture process development with Chinese Hamster Ovary (CHO) or other similar mammalian cell lines in stirred tank bioreactors. • Experience in scaling-up cell culture processes from micro-reactors (AMBR 15 and AMBR 250) and minireactors (3 – 10 liters) to large-scale Single Use Bioreactors (1000-2000 liters) highly desired. • Experience with performing Mass Transfer Coefficient (Kla) studies, determining Oxygen Transfer Rates (OTR) and Oxygen Uptake Rates (OUR) is highly desired. • Previous experience in cell culture development and scale-up of high cell density cultures in fed-batch or perfusion mode (Alternating Tangential Filtration – ATF) is preferred. Previous experience with authoring of CMC sections for regulatory filings is preferred. This job originally appeared on RecruitIreland.com.

2234 days ago