Technology Transfer Specialist

Job Purpose

Reporting to the PET Operations Director, the Technology Transfer Manager will contribute to the development of a global manufacturing footprint of PET Manufacturing Facilities (PMF), 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 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.
• Comply with all aspects if the Company's Quality System.
• Provide input to the Company financial forecasts and budget setting activities; monitor expenditure and highlight any unplanned over or under spends.
• 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.

Education

• Science degree in a chemistry discipline, or a related field.

Professional Experience, Knowledge & Technical Skills

• 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

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