- Reference: 42808
- Job Type: Permanent
- Location: Offaly, Other, Westmeath
- Category: Science, Pharmaceutical & Food
PROCESS DEVELOPMENT MANAGER – Required to join a start up environment. !
This is a unique opportunity to join a thriving organisation currently in the process of developing a number of life changing biologic products to for the market. The environment is fast paced, dynamic enviorment that will offer progression and career development !
This is a lead role within the Development group responsible for the development and validation of cell culture / upstream processes for recombinant antibodies for use. This will include working with CMOs for some of the process development activity and also for technical transfer of the process into the new facility in the midlands.
- 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 practice
- Skills/Experience REquired:
- BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
- At least 3-7 years relevant experience in bioprocess development and/or manufacturing, specifically on cell culture / bioreactor systems.
- 2-5 year’s management or supervisory experience in a bioprocess development and/or manufacturing environment.
- Cell culture, lab-scale and pilot scale bioreactor experience
- Knowledge of protein purification methods would be an advantage
- Use of disposable technologies and leachable studies
- Process characterisation and process validation experience
- Cell bank safety testing
- Good knowledge of regulatory guidelines relating to process development and manufacture including QbD and Risk Management
- Ability to write relevant sections of CTD for regulatory submission
Permanent salary and a competitive bens package on offer !
For a confidential discussion and or more information on the role and organisation , please contact Mary Mullin on 09064 78104 /085 8718281 or email firstname.lastname@example.org
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