CMC Technology Transfer Manager

About Blue Earth Diagnostics

Blue Earth Diagnostics, a subsidiary of Bracco Imaging, is a global company advancing precision molecular imaging to support timely decisions and better patient outcomes. Founded in 2014, we work closely with clinicians and collaborators, bringing deep expertise to the development and delivery of positron emission tomography (PET) radiopharmaceuticals. Our growing portfolio helps uncover disease sooner and guide treatment choices across multiple disease states, including oncology and cardiology. Backed by a dedicated team, we deliver clear answers when decisions matter most. For more information, please visit: www.blueearthdiagnostics.com.

Job purpose

Reporting to the Director of CMC Technical Operations, the CMC Technology Transfer Manager will contribute to the development of a global manufacturing footprint of facilities supporting radiopharmaceuticals, ensure continuous operation and supervise the development of investigational PET radiopharmaceuticals. The post holder will have a high degree of independence and must be able to prioritize their own workload, while working with different stakeholders to advise and support them with their needs.

Main Responsibilities, Activities, Duties and Tasks

• Act as the primary point of contact between Blue Earth Diagnostics and the CDMO's technical team providing them with relevant information and technical support during site set up and after approval.
• Management of third party CDMOs activities ensuring the accuracy and reliability of the data generated.
• Provide oversight of CDMO 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 protocols, reports, risk and impact assessments, SOPs and regulatory submissions.
• Ensure compliance with Good Manufacturing Practices in collaboration with the Quality team.
• Securing high-quality deliverables in a timely manner.
• Develop appropriate end-to-end CMC project plans and integrate these with the overall project plan. Monitor plans, highlight any risks to key milestones and take appropriate steps to mitigate these.
• Ensure timely production and supply of products.
• Delivering milestones within agreed time, resources and cost.
• Comply with all aspects if the Company's Quality System.
• Provide input into the Company financial forecasts and budget setting activities; monitor expenditure and highlight any unplanned over or under spends.
• Monitor and highlight Intellectual Property opportunities, prepare Intellectual Property submissions.
• Ensure all relevant project documentation is stored in an organised manner on the Company shared drive.
• Undertake Continuing Professional Development activities in order to remain an expert in areas of responsibilities.
• Fulfil pharmacovigilance expectations as defined by the Company policy. Other duties as determined by business needs.

Education

Degree or post-graduate degree in a chemistry discipline, or a related field

Professional Experience, Knowledge & Technical Skills

• Experience in manufacturing/quality operations of active pharmaceutical ingredients and sterile drug products.
• Experience with the selection, setting up and oversight of CDMOs, related to the manufacture, analysis and/or supply chain.
• Experience the technology transfer of pharmaceutical manufacturing processes (DS and DP including sterile fill/finish) and quality control methods/
• Deep understanding of scale-up challenges, validation lifecycle management, and regulatory filing requirements.
• Track record with analytical and process development/validation with API and drug product.
• Proven project management experience handling external vendors, contract partners, or global matrix teams.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Good knowledge of US/EU/UK cGMP guidelines and regulatory standards.
• Understanding of industry area including ICH, FDA and EMA guidance relevant to radiopharmaceuticals drug development;
• Experience of writing eCTD Module 3 documents
• Excellent oral & written communication skills.
• Excellent problem-solving, technical writing, and cross-functional communication skills.

Soft Skills – Company Values & Behaviours

• Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.
• Excellent oral & written communication skills.
• Excellent interpersonal skills, including communication verbally and in writing. Ability to influence and build relationships in a global organisation
• Excellent organisational skills, including multitasking, efficiency, punctuality, and project management
• Innate flexibility to work in a small dynamic company environment.