Life Molecular Imaging GmbH (LMI) is the German based Research & Development (R&D) organization and a wholly owned subsidiary of Alliance Medical Group Limited. Our vision is to build our position as an innovator and leading player in the Molecular Imaging 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.
For our approved PET tracer NeuraCeq® and our pipeline of tracers in clinical development we offer the following full-time position, located in our headquarter in Berlin, Germany:
Scientist* Pharmaceutical Development PET-Radiopharmaceuticals - EU
Key Tasks and Responsibilities:
- Coordinate pharmaceutical development activities (processes, methods, materials) for commercial products and products under development.
- Lead activities to select and qualify vendors for critical consumables (e.g. vials, cassettes, dispensing kits, filters), reagents, and excipients.
- Mitigate risks from global supply chain for pharmaceutical materials.
- Support development of dedicated/customized materials and establish manufacturing at CMOs.
- Supplier management and monitoring.
- Align with internal functions (e.g. radiochemistry and analytical development, CMC Project Management, quality, regulatory, supply chain)
- Technical writing and review of GMP and CMC documents (qualification/ validation/ stability plans and reports/ change controls).
Skills:
- Ability to work effectively in a team environment.
- Good communicator.
- Attention to details and diligence, quality oriented.
- Open-minded and motivating attitude.
- Enable decisions.
- Solid understanding of
- pharmaceutical regulations, e.g. GMP, ICH,
- regulatory requirements of pharmaceutical (raw) materials and excipients.
- pharmaceutical analytical methods.
- A dynamic person with a high degree of endurance, flexibility, and mobility (about 10% traveling).
- Computer skills, in particular Word, Excel and PowerPoint.
- Fluency in English.
Experience:
- University degree in Pharmacy (preferably), Chemistry or related science
- Several years of experience in development and manufacturing of parenteral drug products, incl.
- Experience in qualifying materials for pharmaceutical use.
- Implementation of regulations for pharmaceutical materials, excipients, and products.
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 fits this profile, please send us your complete application (Cover letter detailing your interest in this position including your past relevant research and work experience, CV, publication list) as a single pdf document to:
Annekathrin Kirchner jobs@life-mi.com
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.