CMC Project Manager

Life Molecular Imaging GmbH (LMI) is a German-based Research & Development (R&D) organization focused on developing PET imaging solutions for diseases with high unmet medical needs. 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.

To coordinate the development and network expansion activities of our PET tracers we offer the following full-time position located in our headquarter in Berlin, Germany

Ihre Aufgaben

• Plan and execute the CMC strategy for the pharmaceutical development of PET tracers

• Responsible for the set-up, oversight, and extension program of a network of PET tracers contract manufacturing sites

• Manage cooperation with external parties such as study sponsors, CROs, and PET tracer contract manufacturing sites

• Coordinate interaction within LMI internal functions (e.g. radiochemistry and analytical development, quality, regulatory, supply chain) for pharmaceutical development of PET tracers

• Monitor budgets and project timelines, *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. Neuraceq^® - Product Indications And Use

  PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

  Limitations: Limitations of Use A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies., Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.

• Radiation Risk Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

  ADVERSE REACTIONS:

• The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

  DRUG INTERACTIONS

• Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

Ihr Profil

• 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,

• University degree in Science, preferably Chemistry, Biology, or Pharmacy

• 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

• 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, please send us your application as a single pdf document. Don't forget to include a cover letter detailing your interest in this position and your past relevant work experience, a CV, and your publication list in your application.

Kontakt

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program