At a Glance
- Tasks: Lead technology transfer for PET manufacturing, ensuring smooth operations and compliance.
- Company: Join Blue Earth Diagnostics, a leader in innovative radiopharmaceuticals.
- Benefits: Enjoy a dynamic work environment with opportunities for professional development and collaboration.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and diverse teams.
- Qualifications: Science degree required; 5+ years in pharmaceutical manufacturing or quality operations preferred.
- Other info: Ideal for proactive individuals who thrive in fast-paced, collaborative settings.
The predicted salary is between 48000 - 72000 £ per year.
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 prioritise 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 of 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 organisational skills; team player.
- Experience and skills with cross-functional and highly matrixed organisations.
- 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.
Technology Transfer Specialist employer: Blue Earth Diagnostics
Contact Detail:
Blue Earth Diagnostics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Technology Transfer Specialist
✨Tip Number 1
Familiarise yourself with the specific technologies and processes used in PET manufacturing. Understanding the technical aspects will not only help you during interviews but also demonstrate your genuine interest in the role.
✨Tip Number 2
Network with professionals in the pharmaceutical and radiopharmaceutical sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends, which can give you an edge in discussions.
✨Tip Number 3
Brush up on your project management skills, especially in relation to technology transfer processes. Being able to discuss your experience with managing timelines and resources effectively will be crucial in showcasing your fit for the role.
✨Tip Number 4
Prepare to discuss your experience with regulatory compliance and Good Manufacturing Practices (GMP). Highlighting specific examples of how you've ensured compliance in past roles will resonate well with the hiring team.
We think you need these skills to ace Technology Transfer Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in manufacturing and quality operations, particularly in sterile pharmaceuticals or radiopharmaceuticals. Emphasise your project management skills and any specific achievements related to technology transfer.
Craft a Compelling Cover Letter: In your cover letter, address how your background aligns with the responsibilities of the Technology Transfer Specialist role. Mention your experience with CMC documentation and compliance with GMP guidelines, showcasing your ability to manage projects effectively.
Highlight Soft Skills: Given the importance of interpersonal skills in this role, ensure you provide examples of your coaching, facilitation, and organisational skills. Discuss experiences where you've successfully influenced stakeholders or worked within cross-functional teams.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the role.
How to prepare for a job interview at Blue Earth Diagnostics
✨Showcase Your Technical Expertise
Make sure to highlight your experience in manufacturing and quality operations, especially in sterile pharmaceuticals or radiopharmaceuticals. Be prepared to discuss specific projects where you successfully managed technology transfer processes.
✨Demonstrate Project Management Skills
Prepare examples that showcase your project management abilities. Discuss how you've addressed challenges and solved problems quickly in previous roles, particularly in a highly regulated environment.
✨Familiarise Yourself with GMP Guidelines
Brush up on UK/EU Good Manufacturing Practices and regulatory standards. Being able to discuss these guidelines confidently will show that you understand the importance of compliance in the role.
✨Emphasise Communication and Interpersonal Skills
Since the role involves working with various stakeholders, be ready to demonstrate your excellent communication skills. Share examples of how you've built relationships and influenced others in a global organisation.