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- Tasks: Lead projects in developing PET manufacturing facilities and ensure compliance with quality standards.
- Company: Join a pioneering company focused on innovative radiopharmaceuticals and global manufacturing.
- Benefits: Enjoy opportunities for professional development and a collaborative work environment.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: Science degree in chemistry or related field; 5 years' experience in pharmaceutical manufacturing.
- Other info: Ideal for those passionate about project management and quality assurance in healthcare.
The predicted salary is between 36000 - 60000 £ 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.
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. Comply with all aspects of the Company's Quality System.
Provide input to the Company financial forecasts and budget setting activities; 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.
Qualifications:
- 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.
- Strong coaching, facilitation, and organizational skills.
- Excellent interpersonal skills, including communication verbally and in writing.
- Excellent organisational skills, including multitasking, efficiency, punctuality, and project management.
Pensions Project Specialist employer: Blue Earth Diagnostics
Contact Detail:
Blue Earth Diagnostics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pensions Project Specialist
✨Tip Number 1
Familiarise yourself with the latest UK/EU GMP guidelines and regulatory standards. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality, which are crucial for the Pensions Project Specialist 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 current trends, which can give you an edge during discussions with us.
✨Tip Number 3
Brush up on your project management skills, especially in technology transfer processes. Being able to discuss specific examples of how you've successfully managed projects in the past will make you stand out as a candidate.
✨Tip Number 4
Prepare to discuss your experience with writing eCTD Module 3 documents. Having concrete examples ready will show us that you have the necessary expertise and attention to detail required for this position.
We think you need these skills to ace Pensions Project 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 that align with the job description.
Craft a Compelling Cover Letter: In your cover letter, explain why you are interested in the Pensions Project Specialist role and how your background in chemistry and project management makes you a suitable candidate. Be sure to mention your familiarity with UK/EU GMP guidelines and your experience with eCTD Module 3 documents.
Showcase Your Communication Skills: Since excellent communication skills are essential for this role, provide examples in your application of how you've effectively communicated complex information in writing. This could include reports, SOPs, or regulatory submissions you've authored or reviewed.
Highlight Continuous Professional Development: Mention any relevant training or professional development activities you've undertaken to stay current in your field. This shows your commitment to maintaining expertise and aligns with the company's expectations for ongoing learning.
How to prepare for a job interview at Blue Earth Diagnostics
✨Showcase Your Technical Knowledge
Make sure to brush up on your understanding of Good Manufacturing Practices (GMP) and regulatory standards. Be prepared to discuss how your experience aligns with the requirements of the role, especially in relation to sterile pharmaceutical or radiopharmaceuticals.
✨Demonstrate Project Management Skills
Highlight your project management experience by sharing specific examples of challenges you've faced and how you resolved them. This will show your ability to manage timelines and deliverables effectively.
✨Prepare for Behavioural Questions
Expect questions that assess your interpersonal skills and ability to work within a team. Think of scenarios where you've successfully coached or facilitated discussions, as these are key skills for the role.
✨Organise Your Documentation Experience
Since the role involves writing and reviewing CMC documentation, be ready to discuss your experience with eCTD Module 3 documents. Bring examples of your past work to demonstrate your attention to detail and organisational skills.
