Career Opportunity

Quality Assurance Manager EU*

Life Molecular Imaging GmbH (LMI) is a Germany-based Research and Development (R&D) organization focused on developing Positron Emission Tomography (PET) imaging solutions to diseases with high unmet medical need. As a division of the Life Healthcare Group, we are a fully integrated pharmaceutical company with research and development laboratories, access to a network of cyclotrons, radio-pharmacies and imaging facilities. 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 and 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® (Florbetaben 18F) and our pipeline of tracers in clinical development we offer the following full-time position:

Quality Assurance Manager EU*

Main Tasks and responsibilities:

  • Qualify and monitor EU/UK contract manufacturers including assessment for suitability; compliance to the applicable GMP regulations and guidelines including:
    • Handling deviations, OOS-results, change control requests, CAPAs and complaints,
    • Performing and follow-up of GMP-audits at EU/UK contract manufacturing sites.
  • Establish, review, and implement quality standards, specifications, parameters, analytical testing, manufacturing methods and validations in compliance with the applicable GMP regulations.
  • Create and establish internal quality documents and standard operating procedures.
  • Preparation, attendance, and follow-up of compliance inspections by national or international authorities, including implementation of actions.
  • Contribute to the compilation of Periodic Quality Reviews and annual QA management reports.
  • Active participation in discussions on the optimization of processes to efficiently improve the level of quality.

Qualification and experience:

  • University degree or comparable education in a science field (chemistry, biology, pharmacy or equivalent).
  • Several years’ experience in QA in an EU/UK pharmaceutical environment preferably in radiopharmaceutical production, aseptic manufacturing, or contract manufacturing.
  • Solid GMP background and experience working in a EMA/ MHRA regulated environment.
  • Experience in conducting audits.

Skills

  • Attention to detail and quality orientation.
  • Excellent communication, interpersonal and organizational skills.
  • Ability to work effectively in a team environment.
  • Ability to travel 10% in EU/UK as needed.
  • Open-minded, proactive, and motivating attitude.
  • Familiar with Microsoft Office 365 programs.
  • Demonstrated ability to become acquainted with customized software products.
  • Fluency in English

The position is based in our headquarters in Berlin or home-based in Europe. The development of the duties may require occasional travel to the headquarters in Berlin (Germany).

If you want to become part of an entrepreneurial team, assume a wide range of responsibilities and your experience fits the above description, please send us your complete application (Cover letter detailing your interest in this position including your past relevant work experience & CV) as a pdf document to:

Annekathrin Kirchner/ Human Resources
Life Molecular Imaging GmbH
Tegeler Str. 6-7
13353 Berlin
Germany
https://life-mi.com

We are looking forward to receiving your application!

Apply here: Quality Assurance Manager EU

* 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.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    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.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

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

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