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Quality Control (QC) Chemist (m/f/d)
Nuclidium (DE) GmbH
München, Bavaria
Quality control
Radiopharmaceuticals
HPLC
Analytical Chemistry
GMP
QA
NUCLIDIUM, a pioneering radiopharmaceutical startup dedicated to developing innovative diagnostic and therapeutic solutions for high unmet medical needs in cancer care, is seeking a highly motivated Quality Control (QC) Chemist to join our growing team. This role will focus on ensuring the quality, safety, and compliance of our radiopharmaceutical products by performing rigorous testing, analysis, and documentation in line with regulatory and company standards.
Don't miss this incredible opportunity to contribute to cutting-edge precision oncology. Apply now and embark on an exciting journey with NUCLIDIUM! We welcome applicants from diverse backgrounds, including those with limited experience. Your enthusiasm and passion for the field matter most to us.
Quality Control (QC) Chemist (m/f/d)
Activities and responsibilities
- Quality Control Testing: Perform chemical, radiochemical, and microbiological tests on raw materials, intermediates, and finished products. Conduct stability testing to ensure product quality over time.
- Method Development & Validation: Develop, validate, and optimize analytical methods to support product development and manufacturing. Collaborate with R&D and production teams to ensure methods meet regulatory requirements.
- Regulatory Compliance: Ensure QC activities align with Good Manufacturing Practices (GMP) and applicable regulatory standards (e.g., FDA, EMA). Prepare and maintain documentation, including batch records, test results, and validation reports.
- Instrument Calibration & Maintenance: Operate, calibrate, and maintain laboratory equipment such as HPLC, GC, spectrometers, and dose calibrators. Troubleshoot and resolve instrument issues to maintain operational integrity.
- Data Analysis & Reporting: Analyze test results and identify deviations or anomalies. Compile reports and provide recommendations for corrective actions as needed.
- Cross-Functional Collaboration: Work closely with the manufacturing team to support production timelines and resolve quality issues. Support regulatory submissions by providing accurate and timely data.
- Radiopharmaceutical Safety: Follow all safety protocols for handling radioactive materials and ensure compliance with radiation safety standards.
- Continuous Improvement: Participate in quality improvement initiatives to enhance QC processes and efficiency. Stay updated on advancements in analytical techniques and industry standards.
Qualification profile
- Education: Bachelor's or Master's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
- Experience: At least 2 years of experience in a QC role, preferably in a GMP-regulated environment. Experience in the pharmaceutical or radiopharmaceutical industry is highly desirable.
- Technical Skills: Proficiency in analytical techniques such as HPLC, TLC, gamma spectrometry, and other radioactivity measurements. Strong knowledge of GMP, ICH guidelines, and regulatory compliance.
- Other Requirements: Attention to detail with strong analytical and problem-solving skills. Excellent organizational and communication skills. Ability to work with radioactive materials and adhere to radiation safety protocols. Familiarity with Microsoft Office tools (Excel, Project/Merlin Project, Word).
- Travel: Willingness to travel within Europe and North America (approximately 30% of working time).
We offer
- NUCLIDIUM is a high-tech start-up, offering you the chance to make a significant impact on the company's trajectory.
- Full-time permanent position as a QC Chemist.
- You will report directly to the Chief Executive Officer.
- Our location in downtown Munich offers a vibrant and inspiring work environment.
- Regular travel opportunities within the EU (including Switzerland) and North America.
- We offer a competitive salary based on your skills and experience.
- Earliest starting date: 1st February 2025.
Don't miss this incredible opportunity to contribute to cutting-edge precision oncology. Apply now and embark on an exciting journey with NUCLIDIUM! We welcome applicants from diverse backgrounds, including those with limited experience. Your enthusiasm and passion for the field matter most to us.
Dr. Leila Jaafar
Full-Time
, Permanent
Specialist
Updated at
11/29/2024
While applying for the job please refer to jobvector
Workplace
Job location
81675 München
Bavaria
Germany
Good to reach from...
- Augsburg
- Ingolstadt
- Landshut
- Rosenheim
- Freising
- Dachau
Salary
The stated amount is the estimated average gross annual salary for comparable full-time positions.
€ 60,984
About Nuclidium (DE) GmbH
NUCLIDIUM is setting a new standard in the precision oncology landscape by developing best-in-class copper-based radiopharmaceuticals that enable the highest accuracy and accessibility for cancer diagnosis and targeted treatment. With our platform, we can combine flexibly copper radiometals with a variety of highly specific cancer-targeting molecules to develop rapidly novel diagnostic and...
More about Nuclidium (DE) GmbH