- Reference: 45545
- Job Type: Permanent
- Location: Leinster, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
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 cGMP facility.
The Cell Culture Manager will be responsible for the following:
- 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
- Manage technical transfer of company processes into the GMP production facility
- Establish Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture
- 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 audit activity
Applications are welcome from candidates with the following experience:
- 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 and minireactors to large-scale Single Use Bioreactors highly desired.
- Broad knowledge base in routine mammalian cell culture, sterile technique, establishment of cell banks, and expansion of cell lines.
For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your cv to firstname.lastname@example.org
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