CMC Project Manager

at  Life Molecular Imaging

Life Molecular Imaging GmbH (LMI) is a German-based Research & Development (R&D) organization focused on developing PET imaging and radiotheranostics solutions for diseases with high unmet medical needs. Our vision is to build our position as an innovator and leading player in the Nuclear Medicine field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.
To coordinate the development and network expansion activities of our radiopharmaceuticals we offer the following full-time position located in our headquarter in Berlin, Germany:

SKILLS:

• Ability to work effectively in a team environment
• Excellent communication skills
• Attention to detail and quality orientation
• A dynamic person with a high degree of endurance, flexibility, and mobility (5-10% traveling)
• Open-minded and motivating attitude
• Intercultural empathy
• MS Office skills, especially Word, Excel, and Project
• Fluency in English

EXPERIENCE:

• University degree in Science, preferably Chemistry, Pharmacy or Biology
• Several years of experience in project management and (investigational) medicinal product manufacturing in pharmaceutical industry
• Broad understanding of all aspects of CMC including process and analytical development, regulatory and quality requirements
• Experience with radiometal-based pharmaceuticals, PET tracer manufacturing
• Solid understanding of pharmaceutical regulations, in particular cGMP, GCP, and ICH guidelines
• Experience in managing international collaborations and contractors
  If you want to become part of an entrepreneurial team, if you are prepared to assume a wide range of responsibilities, and if your background and personal experience fit this profile, we invite you to submit your application. Don’t forget to include a cover letter detailing your interest in this position and your past relevant work experience and a CV.
  Please submit your application on our website: https://life-mi.com/careers/

We are looking forward to receiving your application!

• The person counts, not the gender! Life Molecular Imaging is committed to diversity, rejects discrimination, and does not think in categories such as gender, ethnic origin, religion, disability, age, or sexual identity. Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment.

• Plan and execute the CMC strategy for the pharmaceutical development of radiopharmaceuticals (e.g. radiotheranostics and PET tracers)
• Responsible for the set-up, oversight, and extension program of a network of contract manufacturing sites for the manufacturing and supply of radiopharmaceuticals (therapeutic and PET tracers)
• Manage cooperation with external parties such as study sponsors, CROs, and contract manufacturing sites
• Coordinate interaction within LMI internal functions (e.g. radiochemistry and analytical development, quality, regulatory, supply chain) for the development of radiopharmaceuticals
• Monitor budgets and project timelines