Job Reference: J5634684
Updated On: 26/03/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a Technology Transfer CMC Manager to join a leading Diagnostics company based in the Oxfordshire area. As the Technology Transfer CMC Manager you will be responsible for providing technical support and oversee technological transfer, manufacturing and supply activities with CDMOs, related to the production of radiopharmaceutical drug product for the business.
Key Duties and ResponsibilitiesYour duties as the Technology Transfer CMC Manager will be varied however the key duties and responsibilities are as follows:
1. You will support the development of a global manufacturing footprint by leading projects to transfer manufacturing processes and QC methods to contract manufacturing organisation (CMO).
2. As the Technology Transfer CMC Manager will also provide technical support to established CMOs.
You will have a high degree of independence and must be able to prioritise their own workload, while working with different stakeholders to advise and support them with their needs.
3. You will act as the primary point of contact between the business and the CMO’s technical team providing them with relevant information and technical support during site set up and after approval.
4. As the Technology Transfer CMC Manager you will take part in the writing/reviewing relevant CMC-documentation such as reports, SOPs and regulatory submissions. Ensure compliance with Good Manufacturing Practices in collaboration with the Quality team. Ensure timely production and supply of the products in collaboration with the Commercial team.
Role RequirementsTo be successful in your application to this exciting opportunity as the Technology Transfer CMC Manager we are looking to identify the following on your profile and past history:
1. Relevant science degree in a chemistry discipline, or a related ?eld.
2. Proven industry experience in manufacturing/quality operations of either sterile pharmaceutical or short-lived radiopharmaceuticals.
3. A working knowledge and practical experience with GMP guidelines and regulatory standards. As well as experience of project management and proven ability to address challenges and solve problems quickly.
Key Words: Tech Tranfer, Technology Transfer, CMC, GMP, Pharma, Pharmaceutical, Diagnostics
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