Technology Transfer CMC Manager

About Blue Earth Diagnostics:

At Blue Earth Diagnostics, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization.  Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.

About the Role:

The company wishes to appoint a CMC Manager who will provide technical support and oversee technological transfer, manufacturing and supply activities with CDMOs, related to the production of radiopharmaceutical drug product for Blue Earth Diagnostics.

Reporting to the VP of CMC & Supply Chain, the Technology Transfer CMC Manager will support the development of a global manufacturing footprint by leading projects to transfer manufacturing processes and QC methods to contract manufacturing organisation (CMO). The Technology Transfer CMC Manager will also provide technical support to established CMOs.

The post holder 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.

Responsibilities:

• Contribute to the initial evaluation of CMOs through on-site visits.
• Act as the primary point of contact between Blue Earth Diagnostics and the CMO’s technical team providing them with relevant information and technical support during site set up and after approval.
• Provide oversight of CMO progress including documenting meetings and review/approval of documentation produced during the site setup project, ensuring the accuracy and reliability of the data generated.
• 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.
• Securing high quality deliverables in a timely manner.
• Delivering milestones within agreed time, resources and cost.

Qualifications and Experience:

• Science degree in a chemistry discipline, or a related field.
• Minimum of 5 years’ experience in manufacturing/quality operations of either sterile pharmaceutical or short-lived radiopharmaceuticals.
• Experience in project management and the technology transfer of manufacturing processes and quality control methods
• Good knowledge of UK/EU GMP guidelines and regulatory standards
• Experience of project management and proven ability to address challenges and solve problems quickly.
• Experience of writing eCTD Module 3 documents
• Excellent communication and interpersonal skills.
• You will have the innate flexibility to work in a small dynamic company environment.
• You must be prepared to travel and be able to travel freely within the European Union and the UK.

How To Apply:

To apply, please submit your CV and a cover letter to hr@blueearthdx.com outlining:

• Why this role appeals to you.
• How your background and skills are suited to this role.

Why Blue Earth Diagnostics?

We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a young and dynamic company experiencing rapid growth, BED prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way.

If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you.

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. 

Blue Earth Diagnostics is an equal opportunity employer.  All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.